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U.S. Department of Health and Human Services

MedSun: Newsletter #38, July 2009

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Newsletter #38, July 2009

Articles

Ongoing Safety Review of Arthroscopic Shavers

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FDA has become aware of instances in which pieces of tissue have remained within certain arthroscopic shavers, a device used in some orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Reports submitted to FDA suggested that the tissue retained was not evident to the naked eye. Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures.

We are concerned about this because retained tissue in these devices can compromise the entire sterilization process. We are actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. As the FDA obtains more information that better defines the situation and determines whether there are specific risks, we will provide that information to facilities, health care providers and the public.

The FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures. Hospitals should consider taking the following steps to minimize any potential risk to patients:

**Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer’s instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.

**Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver handpiece.

If you discover retained tissue in arthroscopic shavers at your facility after following the manufacturer-recommended cleaning procedures, you may file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program (OMB Approval No. 0910-0291). You can report directly to MedWatch by phone at 1-800-FDA-1088, or obtain the fillable form online, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787. These voluntary reports will help us gather additional information related to this problem and assess its public health impact.

This reflects FDA’s current analysis of available information concerning these devices, in keeping with our commitment to inform the public about its ongoing safety reviews of devices. The nature, magnitude and possible public health impact of this situation are not yet clear, and at this point FDA is not recommending that healthcare professionals stop using the device. FDA is considering, but has not reached a conclusion about whether future regulatory action may be warranted. We will update this document when additional information or analyses become available.

If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@CDRH.FDA.GOV or 800-638-2041.

Additional Information:

MedWatch Online Voluntary Reporting Form (3500)
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

MedWatch Voluntary Reporting Form (3500) - Paper
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm

Ongoing Safety Review of Arthroscopic Shavers. FDA Medical Device Safety. July 6, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm170639.htm

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The FDA as a Public Health Agency

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New England Journal of Medicine

A public health approach recognizes that the potential good of a new medical product or policy must be balanced against the potential harm. The FDA has always been a work in progress and updating this work means modernizing scientific and legal regulatory approaches to a host of complex matters. Succeeding will require respecting the tradition of the FDA and its mission of public health.

Additional Information:

The FDA as a Public Health Agency. Margaret A. Hamburg, M.D., and Joshua M. Sharfstein, M.D. New England Journal of Medicine. June 11, 2009.

http://content.nejm.org/cgi/reprint/360/24/2493.pdf

FDA Heads Outline Turnaround Plan. Emily P. Walker. MedPage Today. May 26, 2009.
http://www.medpagetoday.com/Washington-Watch/Washington-Watch/14378

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LabNet

Roche Diagnostics notifies customers of the potential for ACCU-CHEK Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick

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FDA Recall Notice

Roche Diagnostics announced that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCU-CHEK Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in meter kits.

Additional Information:

FDA Recall Notice. May 18, 2009.
http://www.fda.gov/Safety/Recalls/ucm164092.htm

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Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing

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FDA - Office of In Vitro Diagnostics (OIVD) website

On April 30, 2009, CDC issued interim guidance on specimen collection and processing [http://www.cdc.gov/h1n1flu/specimencollection.htm], and on May 1, 2009, CDC issued interim guidance on testing for the novel influenza A (H1N1) virus in regions with few or no reported cases [http://www.cdc.gov/h1n1flu/screening.htm].

These documents provide interim guidance to health care providers and clinical laboratories on specimen collection and testing specimens from patients suspected of being infected with novel influenza A (H1N1) virus. Clinicians and laboratories should refer to these interim guidances frequently for updated information.

Additional information for laboratories:
At this time the novel influenza A (H1N1) virus is not known to differ in the nucleoprotein antigen that is conserved across all influenza A subtypes. The majority of tests that are currently cleared for detection or differentiation of Influenza A virus in human specimens may be able detect the Type A marker in all influenza A viruses including the novel H1N1 strain. None of the cleared tests, however, are able to distinguish the novel influenza A (H1N1) virus from other influenza A viruses (i.e., to specifically identify novel influenza A (H1N1) virus). The majority of the currently cleared tests have unknown sensitivity and specificity to detect human infection with influenza A (H1N1) virus in clinical specimens.

Most importantly, no influenza tests are sufficiently sensitive to rule out an influenza infection, and clinicians must consider clinical and epidemiological criteria along with laboratory testing results. Clinicians who suspect novel influenza A (H1N1) virus infections in humans should obtain nasopharyngeal swabs, nasal swabs, throat swabs, dual NPS/TS swab specimens and/or nasal aspirates, store the specimen following the testing laboratory’s recommendation (usually under refrigeration), and then contact their state or local health department to facilitate transport and timely diagnosis at public health and other qualified laboratories.

Laboratorians should also maintain awareness of unusual findings and report inaccurate testing results or other problems to the device manufacturer and/or FDA. Health care professionals and consumers may report serious adverse events, such as inaccurate results, or product quality problems with the use of influenza detection assays to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

•Online: http://www.fda.gov/MedWatch/report.htm
•Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
•Fax: (800) FDA-0178
•Phone: (800) FDA-1088

Additional Information:

Detection of Novel Influenza A (H1N1) Virus by Laboratory Testing. FDA OIVD website. April 30, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm161623.htm

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False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay

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CDC MMWR

In September 2008, CDC, the Food and Drug Administration (FDA), and state health departments began a nationwide investigation into an increase in false-positive test results obtained with a commercially available West Nile virus (WNV) immunoglobulin M (IgM) capture enzyme-linked immunosorbent assay (ELISA). The investigation revealed that, in the United States, one lot of the commercially available test kits was the source of the false-positive results. That lot was recalled, and a second lot distributed outside the United States also was recalled.

Additional Information:

False Positive Results with a Commercially Available West Nile Virus Immunoglobulin M Assay. CDC MMWR. May 8, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5817a2.htm?s_cid=mm5817a2_e

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HeartNet

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers

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FDA Recall Notice

Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Additional Information:

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers. FDA Recall Notice. May 18, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm166344.htm

FDA Alerts Patients to Medtronic Pacemaker Recall. FDA Press Release. June 11, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm

Patients Alerted to Pacemaker Recall. FDA Consumer Information. June 11, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm

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HomeNet

How You Can Get the Best Results with Home Use Tests

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FDA - Office of In Vitro Diagnostics (OIVD) website

Last month, the MedSun Newsletter featured general information on Home-Use Tests. July's Newsletter provides recommendations as to how you may use home use-tests to get the best results.

Additional Information:

How You Can Get the Best Results with Home Use Tests. FDA OIVD website.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/HomeUseTests/ucm125664.htm

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KidNet

Use Infant Heel Warmers with Care

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By: Diane Dwyer, RN, BSN

FDA Medical Device Safety Website (Article reprinted from April Nursing2009, Volume 39, Issue 4)

The article provides recommendations so as to avoid patient and caregiver complications associated with the use of infant heel warmers.

Additional Information:

Use Infant Heel Warmers with Care. Diane Dwyer, RN, BSN. FDA Medical Device Safety Website. April 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm129270.htm

FDA Patient Safety News (video). Avoiding Infant Burns from Heel Warmers. July 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=88#6

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SightNet

FDA Letter to Eye Care Professionals

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FDA website

FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health. The FDA LASIK website can also be used as a resource for eye care professionals.

Additional Information:

FDA Letter to Eye Care Professionals. FDA LASIK website. May 22, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm154882.htm

Latest on FDA's LASIK Program. FDA LASIK website. May 22, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061421.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period April 1 through April 30. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Nephrostomy catheter 8.5 F 38 25cm 6SH
Manufacturer: Cook Medical Inc
Brand: Catheter Drainage Ultrathane MP Mac.Loc RB
Lot #: 2260385

Problem:
This patient has had nephrostomy tubes placed and replaced beginning the early part of this year. Recently the tube was being replaced as it was nonfunctioning. The string fixation mechanism of the existing catheter was unlocked, but did not release. Attempts at advancing a wire through the catheter were unsuccessful. The catheter was then cut in an attempt to release the locking mechanism. Sheaths were advanced over the tubing; however none of these attempts were successful at removing the catheter. The catheter could not be removed and was clamped. It will likely need to be removed surgically.


Device:

Type: Enteral Feeding Container
Manufacturer: Abbott Nutrition
Brand: Ross Ready-to-hang Enteral Feeding Container
Model #: 00668
Cat #: 31321 FAN 8092

Problem:
We are considering purchasing a new product for our facility-the Ross ready-to-hang enteral feeding container. During the evaluation process, we noted the potential for tubing misconnection and brought it to the attention of the rep. Although the feeding system has a "no IV" label, it is easy to take IV tubing and connect it to the system. If such an event were to occur, a patient who receives enteral feeding intravenously could have a fatal outcome. The following recommendations were made to the manufacturer representative:

1. Significantly increase the diameter of the opening where the feeding is spiked so that if an IV tubing was attempted to be inserted, it would not stay in place. This will require that the Ross patrol pump feeding tube set be modified so that the diameter of the piercing pin is increased to match the opening in the feeding solution container.

2. Tint the spike cap purple to provide a visual cue that the purple feeding tube should connect with the purple tinted cap. Currently, the cap is clear, just as the IV tubing is. (Enteral feeding tubing currently has an orange piercing pin. The company is changing to purple. Having like colors could be helpful in preventing a potential misconnection.)
Members from Risk Management and the Product Committee met with Abbott Nutrition Representative to present the information contained in this report and demonstrate how easy it was to connect the feeding to an IV set. According to the Abbott representative, there have been no reports of such a tubing misconnection to the manufacturer. The recommendations for changes were presented for the representative to take back to the Abbott quality department.


Device:
Type: Endoscopy Pump Tubing/cap Set
Manufacturer: Byrne Medical
Model #: EIP2
Lot #: ST2008-584
Cat #: 7911-4001

Problem:
Staff report that they have been opening packages of endoscopy pump tubing to find that the tubing is cracked and broken upon visual inspection and prior to any use. Specifically, staff report that the tubing is not connected to the cap as it should be. Staff has returned four tubing sets from another lot and is now seeing the same problem in a different lot. The rep has been contacted directly by the endoscopy unit staff and informed of this problem. The product is stored in a cabinet on the endoscopy unit. The product remains in its original box until it is needed for a case. This is the only product stored in that cabinet. To our staff's knowledge, the product comes from the manufacturer via the manufacturer's distributor. When it arrives at the hospital, it comes through our receiving dock and then goes directly to Endoscopy.

Since this event occurred the Endoscopy staff has been in communication with the sales rep. The rep told the staff that the manufacturer has had several facilities complaining of the same findings-cracked tubing upon opening the packaging. The manufacturer believes that the cracks are related directly to the way that the device is packaged in that the tubing is wound too tightly. I have not received any feedback from the manufacturer as of yet.


Device 1:

Type: Light Source, Xenon
Manufacturer: Sunoptics Surgical
Brand: Titan400hp
Model #: S400T

Device 2:

Type: Light Source Headlight
Manufacturer: Luxtec, A division of LXU Healthcare, Inc.
Brand: Ultralight
Lot #: 155Q[?]
Cat #: 00-2900-9

Problem:
During surgical procedure Surgeon wearing 400W Xenon headlight assembly noted left buttock with first to second degree burn from headlight. Headlight source turned off and burn treated and monitored. Final result was severe circular 2nd degree burn to left buttock approx. 6.0cm in diameter with the brightest center section at 2.5cm diameter. Surgery completed with no additional events.

Heat output test was performed. Set up and tested light output and beam diameter at three different lengths. Head light focus and dimmer tested OK. Light source lamp hours 117.9 OK. Estimated 10% damage to fibre optic strands.

Tested for temperature at following distances:
-3 cm distance with 2cm beam diameter: Temp = 120degreeC in 15 seconds
-15 cm distance with 5.0 beam diameter: Temp = 80degreeC in 3 mins
-60 cm distance with 12.5 beam diameter: Temp = 38degreeC in 45 mins.

No additional tests performed. Unit sent to manufacturer for evaluation.


Device:

Type: Tube, Feeding
Manufacturer: Covidien Kendall
Brand: Argyle Salem Sump Tube
Ref #: 7771410
Problem:
Nasogastric (NG) tube placed for nutritional support after failing modified barium swallow in pt. status post stroke. Tube feeding started in the evening with stable vitals. No further vitals until approximately six hours later when patient was having tachypnea and low oxygen saturations. Tube feeds were stopped and portable chest x-ray done. It was missed that the NG was placed in the right lung lobe, but the patient was given respiratory support as per his code status, diuresised, and had tube feeds kept off. Pt. eventually made comfort care per the family and expired. Post mortem exam found the NG tube in the patient's right lung lobe.


OPTHALAMIC

Device:

Type: 27g Needle
Manufacturer: Eagle Labs
Brand: Anterior Chamber Irrigator Bend To Tip
Model #: 27ga Irrigation Anterior Chamber Needle
Lot #: P 5527
Cat #: 110-27-4WS
Problem:
Eye surgeon used a 1cc syringe with BSS to hydrate the corneal incision after a cataract procedure. The cannula on the end of the syringe came off under pressure and struck the 6 o'clock iris root. There was bleeding within the eyes. Patient returned to hospital one week later without improvement of condition. Patient was admitted for oral therapy to promote clotting. The patient was hospitalized for one week, and was seen by a retinal specialist, who reported that there was no retinal detachment, but because of the patient's low pressure, he remained suspicious that the patient might have a cyclodialysis cleft.


OBSTETRICS & GYNECOLOGY

Device:

Type: Permanent Sterilization System
Manufacturer: Conceptus, Inc.
Brand: Essure System
Lot #: 628434
Other #: Contraceptive Tubal Occlusion Device and Delivery System

Problem:
The patient's initial procedure was performed several months ago. During this procedure, prior to attempted placement of the Essure device, a 2cm endometrial fibroid was detached via cautery; however was very difficult to remove. Several attempts were made to remove the fibroid without success and the decision was made to leave it in situ. Essure placement was then attempted. Difficult visualization was reported on the right side as the tubal ostium was somewhat occluded by endometrial tissue and on the left side, it was occluded by area of dissection of the previous fibroid. The patient returned to surgery 3 days later for abdominal pain. During diagnostic laparoscopy, the ESSURE spring was identified partially imbedded in the patient's bowel. The physician successfully removed the spring and the patient tolerated the procedure well.


Device:

Type: Birth Control Device, Permanent
Manufacturer: Conceptus, Incorporated
Brand: Essure
Cat #: ESS305

Problem:
During sterilization procedure, physician fired the Essure Permanent Birth Control device, and did not see the coils come out as usual. The coils were not in the Essure Permanent Birth Control device when it was removed. Coils were not found in patient.


CARDIOVASCULAR

Device:

Type: Lead, Pacemaker
Manufacturer: Boston Scientific Cardiovascular Division
Brand: Fineline II Sterox EZ
Model #: 4469

Problem:
The patient has a complicated surgical history including mechanical MVR. She underwent permanent pacemaker implantation for sick sinus syndrome 2 years ago. She was found on routine interrogation this month to have a non-functioning atrial lead with high lead impedance (which appeared to have started 7 months ago). She has preserved LV EF. She presented for atrial lead revision. At the start of the case, fluoroscopy revealed a complete break in the chronic RA lead 2 cm distal to the subclavian insertion site. A new RA lead (MDT 4076) was inserted. Decision was made NOT to attempt to remove the chronic RA lead due to 1) high risk of back bleeding given high R sided pressures and wide open tricuspid regurgitation with anticoagulation, 2) high risk of pocket bleeding due to adherence of the lead to the pocket, 3) risk of destabilizing the lead with risk of complete lead retraction into the brachiocephalic vein/heart. Although lead fractures are known to occur with pacing leads over time, this case was worth noting because of 1) the severity of the break (total clean break with 0.5 cm disconnection between two ends) 2) the location of the break (not subclavian but rather in the pocket) and 3) the relatively short period of time the lead had been in the patient (< 2 years). Hence it is unclear if there is a lead design issue.

======================
Manufacturer response for Pacemaker lead, Guidant 4469
======================
Technical services was contacted and will give reply regarding issue.


Device:

Type: Lead, Pacemaker
Manufacturer: Medtronic Inc.
Brand: CapSureFix Novus
Lot #: PJN1804955
Model #: 5076-52CM

Problem:
As ventricular lead was being placed, it became immobile and unable to move forward. Apparent scar tissue under the clavicle and outside the subclavian. Decision was made to remove the lead. After extracted it was noticed that the tip was no longer visible. Under fluoroscopy it was visualized to be outside the subclavian vein and adjacent to the clavicle. Decision was made by physician to leave it there and a new sheath and lead were advanced.


Device:

Type: Oxygenator, Cardiopulmonary/ECMO
Manufacturer: Maquet, Inc.
Brand: Jostra Quadrox D
Model #: Jostra Quadrox D
Lot #: 70003778
Cat #: Hmod 2030

Problem:
Crack in the polycarbonate housing of the oxygenator was noted. In the course of 24 hours the crack had gotten larger. It was replaced in a controlled manner per standard protocol. No adverse effects noted.


Device:

Type: Physiological Monitor Module
Manufacturer: GE Healthcare
Brand: Carescape, Pdm
Model #: Carescape

Problem:
Five previous MedSun reports were filed last year. Resolution from GE is still pending. Over fifty PDM, Carescape modules are sitting in a box in storage, which have not been deployed to clinical use since receiving them. Unable to obtain the update or definite time line to when the problems will be resolved. The previous MedSun reports filed were for:
1) NIBP Hardware failure with PDM
2) NIBP Issues with PDM and Tram
3) Rebooting issues in PDM
4) SpO2 issues with PDM
5) Temp Issues with PDM

======================
Manufacturer response for Physiological Monitor Module, PDM (Carescape)
======================
Released software upgrade for Solar 8000i. Upgraded monitors at the hospital. Put PDM’s (Carescape module) back into clinical use into a small pod of the OR’s as a pilot. PDM’s experienced the same failures as mentioned in the MedSun reports filed. Pulled devices out of use. Alerted GE. Solution still the hospital is pending a response from GE, with no update or timeline since. The PDM’s have been out of clinical use for ~ 1 year at this time.


Device:

Type: Solution Warmer
Manufacturer: O.R. Solutions, Inc.
Brand: Or Solutions
Lot #: 1208001
Cat #: ORS-100

Problem:
Staff description: "RN noted Lactated Ringer's had leaked into the solution warmer through the sterile drape. Upon inspection, I noted and circled a 5mm tear in the drape. The tear was not uniform throughout, appeared more like a "melted tear." The attending surgeon, Dr. was made aware. The drape was placed into a biohazard bag, along with the package insert. The solution warmer was sent to BIOMED for a maintenance check.

Check of the warming device showed no malfunction. With temperature set at 105F, the actual temperature at the center of the basin measured 105.8F. Maximum observed temperature around the edge measured 108.4F. The inside of the basin had residue that appeared to be pieces of melted drape material. When the device is first turned on, the edges of the basin get extremely hot before the thermostat sensor gets up to the temperature set point. If there are folds in the drape, heat is not effectively transferred from the water to the bottom of the basin, allowing hot spots to develop. All of our other warmers show signs of drape melting on the bottom of the basin.

Anytime the sterile drape leaks, there is potential for patient infection. No patient injury has been reported so far. If the bottom of the warming basin had better heat distribution this problem could be minimized. Using a drape material with a higher melting point would also help.

We have had this problem repeatedly over the past few years. At least 5-6 times that I can remember that it looked like a melting issue. We have had puncture issues with the drape caused by sharp objects, but that is clearly operator error. Unfortunately, in most of the previous cases the drape was not saved (they are usually contaminated with blood).

OR Solutions maintains that melting only occurs when the drape is not properly seated in the basin and filled with water, but when you put a flat sheet of plastic into a deep rectangular basin, there is no way to avoid folds in the plastic. While in some cases, operator error may have contributed to failures, several incidents happened with well trained individuals who paid attention to the instructions and are very familiar with the units.


Device:

Type: Guide Wire
Manufacturer: Abbott Vascular Devices
Brand: Hi-torque Balance Middleweight Guide Wire, 0. 014", 190 Cm, Hydrocoat
Model #: REF 10011780J-HC
Lot #: 9031781
Cat #: (01) 0 8717648 02598 3
Other #: (17) 110228 (10) 9031781 (91) 3167

Problem:
The device that failed is an Abbott Hi-torque balance middleweight.014, 190cm cardiac cath guidewire. During the procedure, staff was unable to advance a stent over the wire. Staff was able to advance a balloon over the wire, so they did that, and ballooned the vessel. They then took the balloon out and again tried to advance a stent over the wire. Again, they were unable to advance a stent over the wire. Staff removed the wire and noticed that the wire has an irregular "thickness" along its length that prevents a stent from being passed over the wire. The "thickness" almost looks like some sort of a "welding bead" in that it is an area were the wire's metal thickness is greater than it should be.


GENERAL & PLASTIC SURGERY
Device 1:

Type: Tourniquet
Manufacturer: Stryker Instruments
Brand: Smartpump
Model #: 5920-11

Device 2:

Type: Tourniquet Cuff
Manufacturer: Stryker Instruments
Brand: Color Cuff
Model #: 5921-24-135

Problem:
Patient sustained 750 estimated blood loss during the procedure. MD stated tourniquet did not perform, possibly due to stents in Patient's leg, or due to equipment failure.


Device 1:

Type: Table, Surgical
Manufacturer: Stryker
Brand: Vertier Surgical Table
Model #: 0788-300-0005
Other #: Clin Eng Sticker "Loaner 4 4/09"

Device 2:

Type: Handpiece, Surgical Table
Manufacturer: Stryker
Model #: 0788-30-001

Problem:
During surgery the patient was initially placed in trendelenburg position using handpiece. Since the handpiece did not work, they had to operate the table by plugging it in and using the control panel manually. After initial procedure they attempted to reverse trendelenburg position to supine and the handpiece would not work still, so they manually operated again from the control panel (the operations specialist was called and the control box was operated manually to get the patient out of trendelenburg into supine). The patient was then placed into lithotomy. Shortly after this, the head of the bed started moving up and down independently, with no one operating either the control box manually or with the handpiece. The potential for harm was the patient's airway could have been compromised, still under general anesthesia and on a ventilator, or other injury could have occurred, back strain etc. After removing the patient from the OR table, the team attempted to place the bed into a neutral position and the HOB snapped off and broke. This unit was a loaner and had a safety check by clinical engineering prior to use.

FDA Comment: Please see recall information below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72536
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72535
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72534
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72533

Device:

Type: Scalpel, Retractable Safety
Manufacturer: Cardinal Health, Inc.
Brand: Allegiance
Other #: Size 11

Problem:
Retractable Scalpel #11 was used to cut a VAC sponge dressing. The scalpel opened and locked in position as expected for the first cut. It was then retracted and locked in place. The scalpel was picked up a second time by the physician, who passed it from Left hand to Right hand. During passing, the palm of the right hand was stabbed by the blade. At that time, the physician noticed that approximately 1/3 of the blade had slipped out into an exposed position, without any pressure on the Red retract button. The physician also noted that the blade did not retract as it lacerated the hand; it was in a locked position.

The physician's impression was that the red button, which retracts and locks the blade, did not function as expected. The blade should not have slipped out of the retracted position.


GENERAL HOSPITAL

Device:

Type: Automated Syringe Filling System
Manufacturer: Baxa Corporation
Brand: Rapid-fill Automated Syringe Filling System

Problem:
After the spinal block was placed for the scheduled Cesarean section, the patient was inadvertently administered Succinylcholine instead of Ephedrine. The patient became paralyzed and had awareness of difficulty breathing for about 60 seconds. The patient required a brief period of intubation and ventilatory support. The patient recovered satisfactorily from anesthesia.

Investigation: The Rapid-Fill Automated Syringe Filling System (ASF) automates on-line label printing by printing the label information and cutting the finished, labeled syringe from the strip. The label is affixed to one-half of the syringe barrel so that gradations on the syringe barrel are legible and it does not impair the ability to check the medication dosage. The ASF is used to fill and label syringes of Ephedrine (violet-colored label) and Succinylcholine (fluorescent red-colored label). The labeled syringes of Ephedrine and Succinylcholine are stored in the same drawer of the Pyxis unit. A staff member removed the syringe labeled "Succinylcholine" from the Pyxis and administered it instead of the ordered dose of Ephedrine. When the syringe is in the position to allow visualization of the gradation markings on the syringe barrel, only the white-colored backside of the label is visible. Apparently, the staff member did not check the printed medication label prior to administration. A root cause analysis of this occurrence will be completed. An interim measure has been implemented. A yellow-colored sticker that states "Warning: Paralyzing Agent" is affixed to the white backsides of the Succinylcholine labels before they are stored in the Pyxis. There have been no other complaints with this device other than there were some issues with a batch of syringes where the label went over the markings on the syringe.


Device 1:

Type: Omnicell Drug Sys
Manufacturer: Omni Cell Cabinet and PC
Brand: Omnicell Drug Sys
Model #: 344

Device 2:

Type: Omnicell Drug Sys
Manufacturer: Omni Cell Cabinet and PC
Brand: Pc Box For Color Touch
Model #: OSCT

Problem:
Nurse entering in user ID on the Omnicell via keypad and shocked her. Then Omnicell shut down. The pop was heard by several staff members and witnessed by them as well. The shock pushed her back from the Omnicell.


Device:

Type: Software, Surgical Scheduling, Documentation, And Charging
Manufacturer: PICIS, Inc.
Brand: Picis Caresuite
Other #: PICIS 8.0 Service Package 12

Problem:
PICIS locks up during patient care documentation at the "save" function. PICIS locks up only at the save function, allowing RNs to continue to document critical patient data only to discover at the end of the case, that no data will save. In order to get out of the patient chart, the computer must be re-booted. All patient documentation is lost. Nurses are forced to do their best guess as to surgical times, implants, medications, etc and re-chart the entire document. This is a safety issue for patients; RN staff direct their attention from the surgical field to the computer and spend a great deal of time trying to get the software up, and re-chart all the data. This is a healthcare safety issue because guessing what you previously documented live in a surgical environment puts RN staff at great risk for a patient care error, and an omission of critical patient surgical information, thus putting their RN License at risk.

This has occurred with multiple procedures and patients. Our facility has struggled with this issue for months. Information Specialists from our facility reported this issue to PICIS in February 2009. The issue has not been resolved, as of yet, and appears to be getting worse.

We have considered going back to paper documentation for safety, but our electronic PICIS scheduling, documentation and charging system is so ingrained in our processes, it would cripple us to stop now. This ongoing software program leaves us in a difficult position - due to the risk of data loss. The current Government is demanding Electronic Documentation as a Health Care Industry Cost initiative. We desire to be in the spirit of this order. Please assist us in resolving this issue so we may move forward in the spirit of patient safety and accurate electronic documentation.


PHYSICAL MEDICINE

Device:

Type: Bed, Air Fluidized
Manufacturer: Kinetic Concepts, Inc. (KCI)
Brand: Kinair
Model #: 40030A

Problem:
Smelled electrical burning scent. Found motor casing to be very hot on Kin Air low air loss bed. Un-plugged bed immediately, removed patient from bed, removed bed from room, replaced bed with a new regular ICU bed. Company called.

======================
Manufacturer response for Bed - Specialty, KinAir
======================
Upon inspection of bed, one of the blower motors on the right side had ceased, overheating the outer casing, and damage occurred to the double insulated power cable.

See device images:

bed motor casing

bed motor casing label

bed control keypad


CLINICAL CHEMISTRY


Device:

Type: software, laboratory system
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Brand: Vitros 5.1 Chemistry System

Problem:

Clinical lab chemistry analyzer was to have new software version pushed by the company. The company pushed an old version and disabled the analyzer. The equipment was inoperable for over four hours, which would delay any patient testing.


Device:

Type: analyzer, chemistry
Manufacturer: Siemens Healthcare Diagnostics Inc.
Brand: Advia Centaur XP
Model #: XP

Problem:
False positive results reported on five patients. Tests involved were Hepatitis B Surface Antigen, Hepatitis B Core Antibody, and Hepatitis C Antibody. Testing suspended. Vendor service called in to evaluate instrument; no specific cause found. Hepatitis testing sent out to reference laboratory. Corrective reports issued. Appropriate providers notified.


HEMATOLOGY

Device:

Type: analyzer, chemistry
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Model #: CENTAUR

Problem:
Hepatitis A IgM reported as reactive incorrectly. The supervisor realized there was an increase in equivocal and reactive patients. QC (quality control) acceptable, but levels changed; assay failed recalibration. Stopped analyzing the assay on Centaur 3 and moved analysis to Centaur 2. The assay calibrated, with a new reagent pack (lot# 131) and diluent 2 (lot# 33802)and QC was more consistent with past operation. The situation seemed better, but assay was still not performing as in the past. Siemens service was called in to check the instrument and another company was in to check the water system. After service and trying a new lot of diluent 2, it was determined that the old lot of diluent 2 (used only on Hepatitis A IgM) was the problem. We notified Siemens of the problem and sequestered the bad lot of diluent 2 (lot# 33802).

Initially it appeared to be the reagent causing the problem with the analyzer. More follow up by the staff with the vendor revealed that it is a maintenance issue. Device is under full contract with Siemens medical. Several parts were replaced within the system to eliminate the problem. Follow up with pathology will continue.


ANESTHESIOLOGY

Device:

Type: Ventilator
Manufacturer: Cardinal Health

Problem:
During transportation of a patient from one critical care unit to another, the Avea ventilator's battery unexpectedly died after less than five minutes. The ventilator was immediately removed from service and patient was placed on a different Avea ventilator. No adverse outcome to the patient.

Biomedical Engineering received the ventilator and replaced the battery, charged the battery and the ventilator passed testing. The ventilator was placed back in service. A biomed technician recently attended service school sponsored by the manufacturer. The manufacturer suggested adding the procedure of testing and cycling the batteries every 180 days. This was not being done every 180 days and so this step was added to the preventive maintenance task list for the ventilators.


Device:

Type: ET Tube Holder
Manufacturer: Integra Biotechnical LLC
Brand: Universal Bite Block
Model #: 11160
Cat #: 11160

Problem:
While on an ET tube, patient was coughing and ET tube was displaced. When clinical staff tried the release lever for the ET Tube Bite block it would not release. Patient's sats became worse and the lever would not release. It took two people to get it off. Pt had to be reintubated. Health Professional feels the release needs to be stronger and bigger. It became jammed and there was not much leverage for the Health Professional when trying to get it released.

======================
Manufacturer response for ET Tube Holder, Universal Bite Block
======================
They were informed of the scenario of the device failure and were not requested by the Clinicians to come in house for a follow up meeting but have been cooperative.


Device:

Type: Universal Neonatal Heated Ventilator Breathing Circuit
Manufacturer: Teleflex Medical Incorporated
Brand: Hudson RCI Concha Therm
Model #: Concha Therm
Lot #: 02324
Cat #: 380-88

Problem:
Inspiratory breathing limb came into contact with the expiratory limb which caused the inspiratory limb to melt at the contact point. This caused the circuit to leak. Both limbs have heated wire inside, which could cause the melting to occur during contact.

======================
Manufacturer response for Universal Neonatal Heated Ventilator Breathing Circuit, Hudson RCI
======================
No response.


Device:

Type: expiratory filter water trap
Manufacturer: Cardinal Health
Brand: Avea disposable expiratory filter with water trap
Model #: 11790
Other #: Part # is: 11790

Problem:
The issue is with the AVEA disposable water trap which is a disposable ventilator water trap to be used with the AVEA ventilator. On eight known occasions, the water trap easily fractured (broke) off at the connector site for the expiratory hose. In all cases, this disabled the ventilator from delivering air, and patients had to be manually ventilated until replaced, putting patients at potential risk. In several instances, a clinician just "bumped into it" and in other instances the clinician was connecting the vent circuit when the said piece easily fractured.


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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Vascular Hemostasis Devices

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Vascular hemostasis devices are used to stop bleeding from a blood vessel, usually after a medical procedure has opened an artery. During cardiac catheterization, balloon angioplasty or catheter-based procedures, the physician often will obtain access for the procedure through the femoral artery in the patient’s groin. The physician may also use the arteries in the arm, such as the radial or brachial artery. There are several types of hemostatic devices. Some administer an agent that speeds the body’s natural clotting process and stops the bleeding, while others involve a stitch in the femoral artery to close the incision site and stop the bleeding. [1]

Over the past year, MedSun has received 28 adverse event reports associated with vascular hemostasis devices [2]. The reports represent four manufacturers: 12 from Abbott Vascular, 9 from St. Jude Medical, Inc., 6 from AccessClosure, Inc., and 1 from Cardiva Medical Inc. The reports were submitted by 15 hospitals between June 5, 2008 and June 5, 2009. The reported device problems included:

• General Device Failure (8)
• Failure to deploy or improper deployment (4)
• Device did not hold (2)
• Sheath would not split (2)
• Suture material missing (2)
• Balloon burst (1)
• Device lodged in vessel (1)
• Tip broke off (1)

During this time period there were no reported deaths associated with these devices. The patient injuries listed below were reported in 15 of these 28 reports. Injuries reported include:

• Hematoma (7)
• Bleeding (4)
• Surgery (4)

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 30 patient ages were listed as greater than 21 years. Of the reports that listed patient gender, a total of 15 female patients and a total of 13 male patients were involved. Reports may have involved more that one patient.

These MedSun reports contributed to FDA awareness of the device problems. The following recall, describing problems with failure of hemostasis are noted to be associated with the StarClose device manufactured by Abbott Vascular. Reported events involving specific StarClose devices may, or may not, be involved in the recall listed.

Recall # Z-0575-2007
A recall was initiated on January 31, 2007 by Abbott Vascular Inc. for the
StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677, Lot Numbers starting from 43034-6H to 47139-6H
The reason for the recall was premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis. Recall online available,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=50232

Other FDA Articles and Notices of interest discussing Vascular Hemostatis Devices authored by FDA staff.

FDA Patient Safety News
Complications Related to the Use of Vascular Hemostasis Devices, online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=97

Medical Device Safety Alert
Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use - Phase II, online available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070057.htm







Vascular Hemostasis Devices
Device Device Identifiers Event Description
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 681696HAfter an arteriogram, a StarClose device was used to close the artery (common femoral artery left), the device failed and tore a larger hole in the artery. The artery was repaired with suture.
Abbott Vascular Devices/ StarClose No Device IdentifiersA StarClose device was being used on patient post cardiac cath procedure. When the patient got up to ambulate, the device did not hold and the patient had slight bleeding. A pressure device was applied and the patient was put on bedrest for 4 hours. Patient was discharged in a normal timeframe. The patient did not develop any other issues.
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 642096HThe physician was attempting to deploy a vascular occlusion clip when the vascular closure system failed to deploy correctly. The end of the closure system wand twisted 90% and became lodged in the vein. The physician successfully removed the device and performed the procedure successfully with an additional closure system. Manufacturer requested that we return device to them for analysis. Manufacturer is to provide a written report.
Abbott Vascular Devices/ StarClose Lot # 682696HFollowing a closure of an aneurysm in the leg with a covered stent, an attempt was made to close the access in the left groin. StarClose was attempted by the Dr. without success. Pressure was held until hemostasis was obtained.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/Lot # 60026-6HThe Perclose device did not fire. A new device was opened and also did not fire. The patient developed a hematoma which required pressure for 20 minutes prior to discharge from the OR to the PACU.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/ Lot # 690436HThe device did not contain suture.
Abbott Vascular Devices/ Perclose Proglide Catalog # 12673/ Lot # 690066HTwo Perclose vascular closure devices failed to deploy the appropriate stitch in the artery. The vessel was subsequently closed with a device by a different manufacturer. There was no patient harm. The devices were saved but only one packaging was saved.
Abbott Vascular Devices/ StarClose Lot # 670046H Procedure: Angiogram: Iliac/PTA/Stent. The patient's left common femoral artery was accessed for an AP aortogram and angiogram and a StarClose device was used for closure. There was some type of misfiring of the StarClose device which did not allow it to release. The physician then made an incision in the left groin to manually remove the StarClose device and then held pressure manually over the femoral artery for 15 minutes. A hemostatic agent was placed and the incision was sewn shut. The patient tolerated the procedures well.
Abbott Vascular Devices/ StarClose Lot # 720476H A 6F StarClose was flushed and prepped. A guide wire was advanced and the sheath was exchanged for a StarClose sheath. The guidewire and dilator were pulled out and the StarClose was inserted. The top button was clicked down and the trigger was advanced splitting the sheath, but the clip on the StarClose was not deploying. The Dr. tried several times to get the device to deploy. The system was abandoned and manual pressure was held until hemostasis.
Abbott Vascular Devices/ StarClose Lot # 740266H After the sheath was changed to a StarClose sheath, the device was inserted through sheath. It was properly snapped to sheath and raised up to begin splitting, but splitting did not work. It was then noticed that a leaflet on the end of StarClose was kinked and would not advance any further. After several attempts at pulling out the system with no success, the emergency release button was used and the StarClose was aborted. Manufacturer response: the device will be replaced
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot # 700636HA left femoral arteriogram was completed. The StarClose was used on left groin but failed requiring compression and application of a pressure device. Patient was not injured.
Abbott Vascular Devices/ StarClose Catalog # 14677/ Lot# 720676H During an arteriogram the vascular closure device malfunctioned. The sheath didn't split completely and the StarClose device did not deploy. The patient was not injured.
AccessClosure, Inc. / MYNX Lot # F0808102 The patient developed a hematoma about the size of egg after a MYNX closure device was used to close vessel status post procedure. Manual pressure and another brand of closure device were applied. The patient was discharged but was re-admitted 5 days later for fever in the right groin.
AccessClosure, Inc. / MYNX No Device Identifiers A MYNX device was applied to the right groin but device failed. The patient developed a hematoma, and was hypotensive in the Cath Lab. Dopamine was started and another type of wound closure device was applied. The patient was transferred to CCU for observation. The patient became hemodynamically stable and the hematoma resolved. The patient was discharged home.
AccessClosure, Inc. / MYNX Lot # F0827308 When the closure device was deployed, the balloon tip for the device broke off.
AccessClosure, Inc. / MYNX No Device Identifiers A MYNX closure device was deployed in the right femoral artery. Bleeding was noted at site and manual pressure was applied by the physician. Venous sheath was also disconnected at this time per the physician's order, with pressure to the venous site. The site continued to ooze blood. A pressure device was applied approximately 15 minutes later, per the physician's order. Hemostasis was obtained with the pressure device.
AccessClosure, Inc. / MYNX Lot # F0823304 Unsuccessful closure with the device. A MYNX balloon burst while pulling back on device through sheath. It is thought to be device malfunction and not operator error.
AccessClosure, Inc. / MYNX Lot # F0824904 As the physician was attempting to deploy the MYNX device, the balloon expanded but the physician was unable to withdraw the catheter to expose the sealant. After the MYNX was passed off the sterile field, the physician attempted to pull the catheter up, but was unable to do so. Blood loss during the procedure was within normal limits (50-100cc) and a total of 50 cc of radiopaque was used during the procedure. The patient had a palpable popliteal pulse on the right side post procedure and was transported to recovery in stable condition. The physician stated one of every two MYNX devices used is defective.
Cardiva Medical Inc. / Boomerang No Device Identifiers A boomerang device was disengaged but operator unable to retrieve boomerang device. Manual pressure was held and the Dr. was notified. Manual pressure was held until finally the Boomerang device came out. Manual pressure was continued. No injury to patient was noted. The Boomerang device was noted to have a bend in the wire when it was retrieved.
St. Jude Cardiology/ Angio-Seal Evolution Catalog # C610134 Radiology tech was placing Angio-Seal, post Cardiac Catheterization. Post placement of Angio-Seal, a wire was retained. This retained wire was identified while patient was undergoing a stent placement one month later. Intact wire was removed without incident or damage to patient.
St. Jude Cardiology/ Angio-Seal No Device Identifiers This report covers four incidences in which the patient's experienced hematomas. The incidences were within a two week period.
St. Jude Cardiology/ Angio-Seal No Device IdentifiersPatient had a cath and the next day was sitting in bed and felt something pop in the right groin. The patient felt need to go to the bathroom, got up, felt weak, and fell to the floor. The patient was discovered to have a massive bleed with a retroperitoneal hematoma. The patient was taken emergently to surgery and was found to have bled from iliac artery. The surgeon indicated that the Angio-Seal had failed.
St. Jude Cardiology/ Angio-Seal Catalog # 610130 / Lot # 2076405The patient underwent a cardiac cath through a right groin approach. Three weeks later the patient was noted to have decreased pulses in the right leg and was sent back to hospital for evaluation. Angiogram on this day revealed a large 90% flap obstruction of the common femoral artery. It was felt to be hostile and unstable and possibly could cause an acute vascular compromise down the right leg. Urgent surgery was performed. The flap was removed. At the end of the surgery, the patient had a palpable pulse. The pathology report states the mass that was removed was fibrin and blood.
St. Jude Cardiology/ Angio-Seal No Device Identifiers A right groin hematoma developed less than 18 hours after cardiac catheterization resulting in delayed discharge and patient discomfort.
St. Jude Cardiology/ Angio-Seal VIP Catalog # 610310Vessel occlusion at the access site occurred during the cath lab visit. An Angio-Seal device was used as a closure device. The device was inserted per protocol but it malfunctioned. Upon attempting to cinch down collagen plug, the piece used to cinch the collagen plug was not able to be withdrawn. It appeared that the collagen plug was intra-arterial. An initial femoral angiogram revealed arterial occlusion. Subsequently vascular surgery was called emergently. The plug was able to be withdrawn but still remained intra-arterial; flow was restored to the femoral artery. The patient was taken emergently for a cut down and removal of the plug. This was done without immediate complication.
St. Jude Cardiology/ Angio-Seal No Device IdentifiersBleeding occurred after a percutaneous intervention with an Angio-Seal closure device. Manual pressure was held for fifteen minutes, and hemostasis was achieved.
St. Jude Cardiology/ Angio-Seal Catalog # 610310/ Lot # 2023627 The device was removed from the package and assembled; the dilator was inserted into the sheath. The physician removed the arterial access sheath over a guidewire. The Angio-Seal device was inserted into the artery over the existing guidewire as per standard operating procedure. The physician prepared the device to be deployed and noticed that the suture material was missing from the device. He abandoned the deployment, removed the device and applied manual pressure to the groin to obtain hemostasis. Hemostasis was successfully obtained with no sign of hematoma. The manufacturer was notified. Manufacturer representative came on site and re-inserviced staff and physicians on proper use and handling
St. Jude Cardiology/ Angio-Seal Catalog # 610310/ Lot # 2657479 A 6fr Angio-Seal was deployed per MD for vascular closure. The device did not deploy properly causing a tear/dissection of the left femoral artery. The patient was taken to OR for repair.


FDA is currently looking into the other listed device problems.

[Note: The reports have been edited for clarity]

Additional Information:

[1] Tavris, D., Dey, S. & Albrecht-Gallauresi, B. (2005). Risk of local adverse events following cardiac catheterization by hemostasis device use — phase II. Journal of Invasive Cardiology,17 (2).
http://www.invasivecardiology.com/article/4937

[2] FDA MedSun Database
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127686.htm

FDA Recall Notice. Class 2 Recall: StarClose. January 31, 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=50232

Preventing Serious Injuries from Hemostasis Devices. FDA Patient Safety News. April 2002.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=97

Risk of Local Adverse Events following Cardiac Catheterization by Hemostasis Device Use - Phase II. FDA Medical Device Safety.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070057.htm

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Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Fire Associated Reports

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An electrosurgical cutting and coagulation device (and its accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.[1]

Over the past 2 years, MedSun has received 13 reports where fire is association with the use of electrosurgical cutting and coagulation devices [2]. The reports represent devices across 8 manufacturers:
• 8 reports for Valley lab and
• 1 report for the following manufacturers: Arthrocare, Boston Scientific, Megadyne, Karl Storz, Gyrus, Integra LifeSciences Corporation, and Olympus.

The reports were submitted by 12 hospitals between May 2007 and May 2009.

The reported device problems in these reports include:
• 13 reports of fire
• 2 reports of spark
• 1 report of heat
• 1 report of arcing


None of reports involved a patient death. The patient injuries listed below were reported in 9 out of 13 reports:
• Burn
• Re-intubation
• Additional Therapy
• Wound
• Redness
• Tissue damage

Of the reports that listed patient age, 5 had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 2 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 7 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. FDA currently has this issue under review.









MedSun Fire Reports Associated with Electrosurgical Cutting and Coagulation Device.
Device Device Identifiers Event Description
Valley Lab, Brand name: FORCE FX, Type of device: ESU hand piece Model# 34828The Bovie tip spontaneously irrupted into a small flame. There was no harm to patient or staff. The situation was controlled immediately
Karl Storz Endoscopy -America, Inc., Type of device: Monopolar ESU cord Lot #:IE01During a laparoscopic appendectomy, the cautery device attached to a Maryland Kelly Dissector ignited at the level of the cord. The fire spread to the surgeon's gown and deeper into the surgeon's scrubs. The instrument was immediately removed from the patient and the fire was extinguished with the surgeon's hand. Water was doused on the surgeon's scrubs and gown and the patient's drapes. Oxygen was immediately shut off. No harm to the surgeon or patient. Later on, the case continued without incident.
Covidien LP, Formerly known as Valley Lab, Brand name: ESU, Type of Device: Hand switching suction coagulator Lot #: 151616, Catalog #: E2610-6 At the start of adenoidectomy surgery, a tongue blade and mouth gag were inserted and the mouth was opened for exposure. A red non-latex Robinson catheter was placed transnasally and brought out transorally to help elevate the palate for exposure of the nasopharynx and access to the nasopharynx. At the start of this adenoidectomy, a method of fulguration, using suction cautery, an apparent oxygen leak resulted in a spark. The red non-latex Robinson catheter ignited, and which rapidly began to smolder. A fire estimated to be the size of a fifty cent piece was observed in the oral cavity. The endotracheal tube and the red Robinson were immediately removed from the patient and the oral cavity was doused with saline, and then suctioned out. The patient was re-then intubated with an endotracheal tube. Immediate examination of the oral cavity and larynx revealed that the patient had a 0.5 cm x 2 cm burn on the left lateral tongue, as well as an 8 mm x 8 mm burn on the buccal mucosa of the right lateral lower lip. All just inferior to the crease of the oral commissure. The area was immediately iced. The burns continued to be iced and were classified as superficial and minor by the physician burn specialist. It was later treated with Neosporin. Despite no evidence of burn on the endotracheal tube, it was removed from the patient. The decision was made to confirm that there was no airway injury and direct laryngoscopy and bronchoscopy was performed with confirmation of no airway injury to the larynx or trachea to the level of the carina.

Uncuffed ETT had a large air leak that increased when neck hyperextended; 02 flow rate was high at 89%-92% at the time of event; there was no soaked gauze throat packs in place; there was red non-latex Robinson catheter in mouth; and diluted Hibiclens was being used as a dental mirror defogging agent.
Covidien Valleylab, Device#1: Brand name: Force FX-C, Type of device: ESU unit, Device#2: Type of device: ESU hand piece Product# Unknown Patient under conscious sedation for insertion of portacath for chemotherapy into right external jugular vein. ESU pencil was being used to control bleeding. Patient was receiving 6L (liters) of oxygen via facemask and surgical site had been prepped with Chloraprep (which contained 70% alcohol). Anesthesiologist saw 2 separate flames: one behind patient's right ear and one on right side of facemask.

Anesthesiologist pulled off facemask and patted flames with blue towel. Scrub poured a bowl of sterile saline on patient's face and surgeon pulled all drapes off of patient. The procedure was abandoned, and the patient examined and wounds dressed. The patient was taken into recovery and seen by a burn surgeon and plastic surgeon. Second-degree burns were found at right corner of mouth, at the base of her right ear and right side and back of her neck. They did not find any wounds in nose or mouth and the patient will have no respiratory consequence. An ophthalmologist found no injury to her eyes.

It is not known for sure what caused the adverse event, but after discussion, the causation theory is that a spark or heat from the ESU pencil ignited the blue cotton drape that must have had remnants of the alcohol-based prep used to cleanse the skin for surgery. The oxygen likely pooled in high concentration around the face mask and near the table at the base of the neck and acted as an accelerant. Chloraprep with Tint, 26mL applicator, was being used at the time of event.
Valleylab, Device#1: Brand name: Suction Coagulator, Type of device: ESU hand piece; Device#2: Type of device: ESU unit Device #1: Model #: E2505-10FR, Device#2: Model# Force FXA patient was in the OR for PE tube placement and adenoidectomy. During the procedure it was noted that the tip of the suction catheter ignited. This was immediately recognized and the suction catheter was removed and the flame extinguished. Patient was assessed and no injury, including airway trauma or burn noted.

The site reported the manufacturer told hospital that if the tip of the suction catheter becomes blocked with material, there is the potential for this material to ignite once the device is turned on.
MFR#1: Gyrus Medical, Inc. Device#1: Type of device: ESU Cable Accessory; MFR#2: Covidien Valleylab, Device#2: Brand name: Force FX, Type of device: ESU unit; MFR#3: Boston Scientific Corporation, Device#3: Brand name: Titanium Wedge electrosurgical Monopolar, Type of device: Electrode tip Device#1: Model #: RAC-B Catalog #: 31880110, Device#2: product#: Unknown, Device#3: Catalog# 880-311 Resectoscope cord caught fire while in use by physician. The fire was in the cord only, the tip was not involved. The duration of the fire was 2 seconds. The electrosurgical machine was set to maximum (120 W Coag/ 300 W cut) Patient had a 1 cm area of redness on penis. No treatment required.
Covidien Valleylab, Brand name: Electrosurgical pencil, Type of device: ESU hand piece Model #: 145436 Lot #:146503Using general anesthesia via mask, and cautery, about 1 minute into procedure flames under drapes at right side of face. Second degree burns occurred pt face.
Integra LifeSciences Corporation: Brand name: Bipolar forceps Model #:285-188Bipolar forceps burst into fire at junction where forceps is connected to the bipolar cord. Fire extinguished by itself. No harm to patient. Disposable bipolar cord came from flap pack.
Olympus Surgical and Industrial America Inc: Brand name: ESU active cable Catalog #:AO35BDuring laparoscopic cholecystectomy procedure, the end nearest to the cautery machine of the cautery cord caught fire and burned through. No harm to patient or staff.
MEGADYNE Medical Products, Inc., Brand name: Bovie tip, Type of device: ESU hand piece Catalog # 139926 Lot # 813306, Model# +M1160001399261HThe device flared at the tip when with an attempt to use it outside the patient. The case was completed successfully using another device.
Covidien Valleylab, Type of device: ESU suction coagulator electrode Model#:E2505-10FR Lot #:127510While the surgeon was cauterizing the adenoids, the oral cavity caught fire. Saline solution was poured into the mouth. There was no injury to the patient.
VALLEYLAB, Brand name: electrosurgical unit Product# Unknown During a tracheotomy the patient's O2 saturation began to drop. This required an increase in oxygen to 100%. A spillage of oxygen out of the mouth occurred into the area of the wound. There was a short flash of fire on the chest secondary to electrocautery. The fire was put out with sterile water. The patient's chest hair was singed. No apparent burn
Arthrocare Corporation, Brand name: Coblator II Procise EZ Wand with Integrated Cable, Type of Device: ESU Hand piece Model# EC8870-01, Lot# L102770-ACoblator being used for hemostasis in tonsillectomy procedure. The wand got hot, with apparent "arcing" to adjacent tissue, causing minor damage.

Additional Information:

[1] Code of Federal Regulations Title 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=878.4400

[2] FDA MedSun
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127686.htm

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Summary of MedSun Reports Describing Adverse Events With Electrosurgical Cutting and Coagulation Devices: Patient Burns

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An electrosurgical cutting and coagulation device (and its accessories) are devices intended to remove tissue and control bleeding by use of high-frequency electrical current. [1]

Over the past 2 years, MedSun has received 36 reports where patients receive a burn in association with the use of electrosurgical cutting and coagulation devices [2]. These reports represent devices across 15 different manufacturers:
• 18 reports for Valleylab,
• 4 reports for Arthrocare,
• 3 reports for ConMed,
• 3 reports for Intuitive Surgical,
• 2 reports for Boston Scientific,
• 2 reports for Megadyne,
• 2 reports for Olsen, and
• 1 report for the following manufacturers: Angiodynamics, Mizuho, Salient, Cardima, Gyrus, Encision, Depuy Mitek, Cardinal Health.

The reports were submitted by 30 hospitals received Between May 2007 and May 2009.

The reported device problems in these reports include:
• Degraded insulation
• Arcing
• Spark
• Heat
• Holes


None of reports involve a patient death. The patient injuries listed below were reported in 18 of 36 reports noted to be associated with patient burn:
• 3 reports of 3rd degree burn
• 3 reports of tissue damage
• 5 reports of additional therapy/surgery
• 2 reports of aborted surgery

Of the reports that listed patient age, six reports had a patient age listed as less than 21 years and 30 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 23 reports involved female patients and a total of 8 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems.










MedSun Reports Associated with Electrosurgical Cutting and Coagulation device and Patient’s Burns.
Device Device Identifiers Event Description
ANGIODYNAMICS, INC. Brand name: STARBURST SEMI-FLEX, Type of device: Catheter, ablation, RF, tumor Lot # 952314, Model # 700-102-615 Patient had femur osteoid osteoma. While undergoing radiofrequency ablation of femur tumor in interventional radiology a probe was placed, and it did not work at the site of the tumor. The probe did cause a burn of approximately 2 cm x 1 cm on the skin of the patient at the insertion site. Replaced probe with another one and it worked appropriately. Patient recovering without incident.
ValleyLab, Brand name: FORCE FX, Type of device: ESU Product# Unknown Physician wanted to utilize the harmonic scalpel yet pressed ESU foot pedal instead of harmonic scalpel foot pedal. Patient experienced burn of less than 0.5 cm on upper left abdomen when the ESU endoshears were mistakenly activated.
MFR#1: CONMED ELECTROSURGERY, Device#1: Type of device: ESU device, MFR#2: Olsen Medical, Device#2: Type of device: electrosurgical forceps Device#1: Catalog # 20-1370, Model #5000, Lot #003163, Device#2: Catalog#: 20-1310 The physician was performing a tonsillectomy. It was noticed that the patient had received a burn to the upper lip at the point of contact with the bipolar forceps.
MIZUHO AMERICA, INC., Brand name: BAY PROBE INSULATED BLUE WITH SPRING, Type of device: Transnasal Transsphenoeidal instrument set Model # ISOLATED BAYONET SPRING 110MM ITEM 07-824-02 During transnasal transsphenoidal (TNTS) surgery, the physician used the bay probe insulated blue with spring (bovie stick) inside the patient's nose. Physician noted a burn on the patient's left base of the nose, about 1 cm. Physician inspected the bay probe insulated blue with spring; there were two holes in the insulation.
SALIENT SURGICAL TECHNOLOGIES, INC., Brand name: AQUAMANTYS 2.3 BIPOLAR SEALER, Type of device: ESU Device #1: Model # Aquamantys 2.3 Pediatric patient taken to surgery for liver mass. A bipolar electrosurgical device was used during the procedure. A grounding pad was placed on the left shoulder. After the procedure, it was discovered that the patient sustained two burns to the left shoulder area. The first burn was a 1.5cm.x1cm full thickness burn and located on the superior aspect of the left shoulder, slightly posterior. The second burn was also full thickness, and measured 2cm x 3cm and was located on the upper back just lateral and inferior to the spine of the scapula.
ARTHROCARE CORPORATION, Brand name: Coblator II procise EZ wand with integrated cable, Type of device: ESU hand piece Model # EIC8870-01, Lot # L123570-ASurgeon using coblator for dissection/hemostasis during tonsillectomy. Small area of metal at the tip of the insulated hand piece became exposed and conducted energy to patient's tongue, resulting in approximately 1cm burn to the right proximal area. No treatment needed.
MFR#1: CARDIMA, Device#1:Brand name: Intellitemp Energy Management device, Type of device: Cardiac RF ablation, MFR#2: Covidien ValleyLab, Device#2: Brand name: Force FX, Type of device: ESU unit, Device#3: Type of device: ESU disperser electrode Device#1:Model # 0075-04435, Catalog # 11-081008, Device#2 and 3: Product# UnknownThe patient was admitted for an atrial ablation procedure. The thoracotomy incision was made and the Valleylab Force FX Bovie was being used along with the Valleylab grounding pad. During the ablation portion of the procedure, the grounding pad was disconnected from the Valleylab Machine and connected to the Cardima Intellitemp Machine. The ablation equipment was then connected to the Valleylab Machine and after the ablation was complete, a burn was noted on the patient's right buttock, where the grounding pad was placed.
VALLEYLAB, Brand name: REM POLYHESIVE II, Type of device: ESU grounding pad Catalog # E7507, Lot #125319The cautery/ESU grounding pad was placed on the patient for a port removal procedure. When taking the pad off the patient, a reddened area around the edge of the pad was seen with some breakdown of the skin at the cord entrance site. The wound was classified as a small blister or a burn injury at the site.
ARTHROCARE CORPORATION, Brand name: Arthrocare, Type of device: Arthroscopy wand Catalog # ASC4250-01, Lot # A226570-A When drapes were removed the physician observed a tract like appearance on the medial aspect of patient's left knee (operative leg). It was described as looking like an "inside out" burn.
ARTHROCARE CORPORATION, Brand name: Coblation hand piece, Type of device: ESU handpiece electrode Lot#: B207570-AThe patient was undergoing a tonsillectomy and adenoidectomy. The surgeon was using the hand piece inside the tonsillar area to remove the tonsils and adenoids. The surgeon stated that while he was using the hand piece inside of the patient's throat he saw it "arc" causing a superficial burn. Both pieces of the apparatus were removed and sent to the biomedical department. The sales representative was also notified of the incident.
GYRUS MEDICAL, INC., Brand name: Everest Bipolar Bicoag, Type of Device: ESU Forceps Model#: 3005 5MM, 33CM, Lot#: 7352014 The physician was using the Everest bipolar cutting forceps when it was noted to be burning the tissue, sticking to the tissue and ripping it. The device was cleaned by the scrub nurse with no improvement. The procedure was stopped
COVIDIEN VALLEYLAB, Device#1: Brand name: FORCE FX-C, Type of device: ESU unit, Device#2: Type of device: ESU hand piece Product# Unknown Patient was under conscious sedation for the insertion of a portacath to infuse chemotherapy into right external jugular vein. ESU pencil was being used to control bleeding. The patient was receiving 6l (six liters) of oxygen via facemask and surgical site had been prepped with chloraprep (which contained 70% alcohol). The anesthesiologist saw two separate flames, one behind patient's right ear and one on right side of facemask. Anesthesiologist then pulled off the facemask and patted flames with blue towel. Scrub (staff member) poured a bowl of sterile saline on patient's face and surgeon pulled all drapes off of the patient. Procedure was abandoned, and the patient was examined with the wounds dressed. The patient was taken into recovery and seen by a burn surgeon and plastic surgeon. Second degree burns were seen at the right corner of mouth, at the base of her right ear and right side and back of her neck. They did not find any wounds in nose or mouth and the patient will have no respiratory consequence. An ophthalmologist found no injury to their eyes. It is not known for sure what caused the adverse event, but after discussion, the causation theory is that a spark or heat from the ESU pencil ignited the blue cotton drape that must have had remnants of the alcohol-based prep used to cleanse the skin for surgery. The oxygen likely pooled in high concentration around the face mask and near the table at the base of the neck and acted as an accelerant..
ARTHROCARE CORPORATION, Brand name: Coblator II Procise XP, Type of device: ESU Coblation electrode Catalog#: EIC8872-01, Lot#: R727470-A Patient received anesthesia for tonsillectomy and adenoidectomy using a coblator. Equipment checked preoperatively for defects and visually appeared to be normal in appearance. Patient sustained burn to right side inner bucchal mucosa. Coblator wand inspected and found to have missing insulation on external surface of the wand. Injury documented with images on digital camera./TD>
CONMED ELECTROSURGERY, Type of device: ESU suction coagulator electrode Lot#: 07FHL05 Physician was doing an adenoidectomy on this patient. They were using the bovie and thinks there was a small break in the coating of the instrument that caused the patient burn. Dr. stated that there was a small area on the uvula that was affected.
COVIDIEN VALLEYLAB, Brand name: FORCE II, Type of device: ESU unit Model#: 51500 During a c-section the physician was holding a hemostat. When the cautery was used on the hemostat, it burned a hole in the glove, causing a small burn to the physician's thumb. The physician reported the burn to be the size of a pencil eraser. The hemostat was shiny, the first time the physician had seen it. No adverse outcome to patient.
VALLEYLAB, Device#1: Brand name: SOLID STATE ELECTROSURGERY FORCE IC, Device#2: Type of device: ESU needle tip electrode, Device#3: Type of device: ESU suction coagulation electrode Device#1: Model# 590B; Device#2 and # Product# Uknown Patient was scheduled for a tonsillectomy and adenoidectomy. Patient had a previous history of adenotonsillar hypertrophy that was thought to cause dysphagia for solid consistencies. During the surgery, yet after the dissection of the first tonsil, a 4-mm right lower lip burn was noticed. Ice was immediately placed on the area in addition to a layer of Vaseline. The cautery, both needle-tips and suction were disconnected and sent to biomed for evaluation. The rest of the procedure continued without incident. After the procedure was completed, the surgeon referred the child to a plastic surgery specialist. The surgeon involved also contacted the plastic surgeon to discuss the case and identify any immediate interventions. The biomed completed an inspection of the equipment. All equipment passed visual inspections, which included no evidence of nicks, cuts or abrasions. Tests revealed that the equipment met manufacturer's specifications of output and voltage.
MFR#1: ENCISION, INC., Device#1: Brand name: AEM, Type of device: Active electrode monitor, MFR#2: COVIEDEN VALLEYLAB, Device#2: Brand name: Force II, Type of device: ESU generator /Device#1: Model# Encision, Device#2: Product# Unknown Per the physician, the patient received a small electrical burn to the upper right quadrant of the abdomen. The grounding pad, as well as the cautery cords was properly connected. No alarms sounded and the equipment functioned without shutdown. The burns were received near the very end of the case, when the ball tip cautery was being used inside. The trocar was also in use, which has an eyepiece lens attached at a 90 degree angle. When the doctor moved the lens from the patient's abdomen, the scrub tech saw the red spots on the patient, and an investigation immediately began. The red spots were directly under the lens placement and were the width of the lens. The doctor had already finished with the cautery at this point. It was immediately removed and taken out of service. The company representative was contacted. The cautery cords were left intact in the machine for the clinical equipment staff to check and investigate further. There were no visible breaks in the insulating sheaths on the green cautery equipment. The OR supervisor came to the operating room to view the burn. No further treatment was required for the patient, as the physician instructed for the area to be left open. The burn area totaled approximately 1 inch in diameter, was reddened with about three small whitish streaks inside the reddened area. No blisters were observed. This event could not be duplicated. We tried to touch the cautery tip to the eyepiece but could not because of the inflexibility of the cautery. An active electrode monitoring device was also used during this case, and it did not alarm for any stray current. The ESU and the active electrode monitor were both checked by clinical equipment and both devices functioned within normal established limits. The active electrode monitor is under a service contract and was only checked for electrical safety. The ESU received a PM approximately five months prior and functioned within normal established limits at that time.
MFR#1: BOSTON SCIENTIFIC CORP., Device#1:Brand name: RF 3000, Type of device: RF Ablation System; MFR#2: Covidien Valleylab, Device#2; Brand name: Standard Polhesive, Type of device: ESU return electrode pad Device#1: Catalog# CS545, Model# RF3000; Device#2: Catalog# E7506, Lot# 128795 Patient underwent a liver ablation under CT guidance. After the ablation was done, the grounding pads were removed from patient's thighs. Once the grounding pads were removed, the burns were noted on the lower and upper part of the left thigh pad and the lower right thigh pad. The burn on the lower right thigh was worse than the left.
COVIDIEN VALLEYLAB, Brand name: FORCE FX, Type of device: ESU generator Product# Unknown A spark was noted at the time of the tracheostomy at the insertion site, while a bleeder was being cauterized. Oxygenation was stopped immediately, the endotracheal tube removed, and a tracheal tube inserted. The trachea was flushed with normal saline, cleaned and suctioned. A fiber optic evaluation of the trachea and bronchi was done, which revealed a possible second degree burn.
MFR#1: TRI-ANIM, Device#1:Brand name: Metzenbaum, Scissors, Type of device: Surgical Scissors, Device#2: Type of device: Scissors handle, MFR#2: Cardinal Health, Device#3: Brand name: Presource Custom, Type of device: ESU cable; MFR#3: ConMed Electrosurgery, Device#4: Brand name: SABER, Type of device: ESU unit, Device#5: Type of device: ESU Dispersive electrode Device#1: Model# 810-01-21218, Lot# 44691, Device#2: Product# Unknown, Device#3: Catalog# SID23MCUB, Lot# 468976; Device#4 Model# 60-5600-02, Device#5 Catalog# 410-220 Areas of endometriosis were excised, utilizing monopolar scissors, from the right and left posterior broad ligaments, the right posterior cul-de-sac, and the right and left anterior cul-de-sac. After completing the last part of the procedure, the right posterior cul-de-sac, the surgeon noticed a cautery injury on the posterior wall of the uterus, which was made hemostatic with bipolar cautery graspers. The surgeon then noted this on the medial pole of the right ovary and on an approximately 1.5 cm segment of the right fallopian tube. It appeared that somewhat less than half the diameter of the right tube had been cauterized. Fragments of black plastic material were noted in the pelvis, which seemed to be portions of insulation from the monopolar scissors. The scissors were removed and inspected. There were clear defects in the insulation on the scissor tip, and evidence of heat damage to the distal tip of the scissor shaft itself. The bovie machine settings were coag 40 and cutting 40.
COVIDIEN VALLEYLAB, Device#1: Brand name: COOL TIP, Type of device: RF ablation controller; Device#2: Brand name: Cool TIP, Type of device: Peristaltic pump; Device#3: Brand name: COOL TIP, Type of device: RF ablation system; Device#4: Brand name: COOL TIP, Type of device: RF ablation grounding pad; Device#5: Brand name: COOL TIP, Type of device: RF ablation electrode kit Product# Unknown A patient was treated with radio frequency ablation for an osteoid osteoma of the left femur. Upon completion, a burn under the grounding pad was noted. The patient also required surgery to remove a left thigh necrotic seroma status post radio frequency ablation (rfa). Two grounding pads had been used, one on each thigh. A draining sinus was also noted along the initial application port of the probe. This was resected during the subsequent surgery
DEPUY MITEK (A JOHNSON AND JOHNSON COMPANY), Brand name: VAPR, Type of device: ESU Irrigation, suction system Product# UnknownVAPR system was used for arthroscopic surgery. It was noted during surgery that the suction had not been set up correctly causing the heated fluid to pool and cause the burn. There was not a continuous flow of irrigate. Equipment was unrecoverable and had already been thrown away or cleaned. Patient complained of burning sensation on neck in post anesthesia care unit. A 6 x 3 inch area was noted with two blisters anterior to neck. Iodoform and gauze dressing applied. Family instructed to continue Silvadene and gauze dressing after discharge for ambulatory surgery.
VALLEYLAB, Brand name: BOVIE FX, Type of device: ESU device Model# FX Surgeon noted a bovie spark. After surgery the surgeon noted that there was a small hole on the small finger of his right glove. His small finger had a burn where the spark had gone through glove; burn treated with Silvadene; no other treatment needed. Equipment was checked by biomed; no problems found and it was returned to service.
BOSTON SCIENTIFIC, Device#1: Brand name: RF 300 RADIOFREQUENCY SYSTEM, Type of device: ESU, RF Ablation; Device#2: Brand name: Coaccess Introducers set, Type of device: ablation Electrode Introducer; Device#3: Brand name: Leveen Superslim Needle Electrodes, Type of device: RF Ablation Electrode Device#1: Model#26-220, Catalog# M001262200, Device#2: Catalog# 26-225, Model# M001262250, Device#3: Catalog# 26-228, Model# M001262280 At the end of the radio ablation procedure, the radiologist noted a posterior shoulder burn near the entrance of the radio frequency needle. Metal hemostat was used by radiologist (per recommendation of the Boston scientific sales representative that was present for the procedure), to stabilize the needle in the patient's lung, thus preventing the tip of needle from moving when ablating tumors. Visual examination of the radio frequency needle and introducer set with hemostat still attached was done following the procedure. A break in the insulation sheath of the introducer was noted
COVIDIEN (VALLEYLAB), Brand name: ESU Hand piece Product# Unknown The physician laid the hand piece, which had been previously used, on the patient's chest. It began to burn the skin. The physician immediately picked it up, but the skin was already burnt. The burn was a half inch long. The hand piece was not activated (the button was not pushed) and should not have been hot.
MEGADYNE MEDICAL PRODUCTS, INC., Brand name: EZ CLEAN, Type of device: ESU electrode Catalog# 0014A, Lot# 71330 During intraoperative use of bovie tip, 4" EZ clean caused burn on patient's left breast due to failure of protective insulation on tip. Patient has multiple dermal burns approximately 1cm in diameter on the left breast.
VALLEYLAB, Brand name: FORCE TRIAD, Type of device: ESU device Product# Unknown Patient was burned during her procedure by one of the instruments being used. Events discussed with MD who referred to them as 3rd degree burns along incision line and was able to excise the damaged tissue. According to the information provided by the OR techs, there was never any spark, or abnormality during the case until the end when the retractors were removed. At that time the area was noted to be red. This machine was brand new and had been tested and cleared upon delivery by biomedical engineering. Biomedical engineering has examined the equipment and they are unable to replicate the error / problem.
VALLEYLAB, Brand name: FORCE TRIAD, Type of device: ESU device Product# Unknown Patient was burned during her procedure by one of the instruments being used. Events discussed with the MD who referred to them as 3rd degree burns along the incision line and was able to excise any/all damaged tissue. According to the techs there was no sparks or abnormalities until the end of the procedure when the equipment flashed an error and stated notify biomed. The equipment was removed from service at this point. It was not until this case that they realized that there was an equip issue as this was patient #2 with the same burn as the case before.
COVIDIEN VALLEYLAB, Brand name: ESU PENCIL, Type of device: ESU Monopolar active electrode Catalog# E2516W, Lot# 119864 Small area of pt skin around incision site burned with use of cautery. The cautery was being used inside of neck and slipped. Small burn noted pink in color on upper left hand side of incision at end of case. Antibiotic treatment and 2x2 tegaderm placed.
OLSEN MEDICAL, Brand name: OLSEN, Type of device: Bovie Extender Lot# 110802 During a partial glossectomy, a superficial burn was noted just right of midline of the patient's lower lip and corresponding to the edge of the bovie extender. Extender was immediately removed. The inside rim of the extender, about 1/4 inch, was noted to have what appeared to be crack in the sheath. Char marks on exterior of extender and outer plastic coating appears melted.
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device PRODUCT # Unknown During robotic assisted surgical procedure for laparoscopic hysterectomy with shears set at recommended level of 38 coag, arcing occurred causing burn to uterine tissue. No harm to patient since uterus being removed. Tip cover inspected before procedure and placed on shears according to company recommendations
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device Product# Unknown Arc/spark occurred during use, a few minutes into case. Burn to uterus resulted. No harm to patient since uterus being removed. Tip cover then noted to have holes. Removed and replaced. A machine setting was at 38 coag per manufacturer recommendations. Also tip cover inspected prior to application using gage unit and applied as recommended.
INTUITIVE SURGICAL, INC., Brand name: DAVINCI SURGICAL SYSTEM, Type of device: ESU shears cover, Robotic device Product# Unknown Arc/spark occurred during robotic assisted surgery through scissor guard / accessory tip cover causing burn to uterus which was being removed. No harm then to patient. A setting for shears was at 38 coag which is recommended level. Tip cover inspected prior to application using gage provided by company. Also application of tip cover performed according to recommendations.
MFR#1: COVIDIEN VALLEYLAB; Device#1: Brand name: HANDSWITCHIN ROCKER SWITCH PENCIL, Type of device: ESU pencil; Device#2: Brand name: Force 2, Type of device: ESU generator; MFR#2: Megadyne Medical Products, Inc., Device#3: Brand name: E-Z Clean Blade Electrodes; Type of device: ESU electrode Device#1:Catalog# E2515, Lot# 1387182013-03; Device#2: Model# Force 2-2PCH; Device#3: Catalog# 0012M, Lot# 2010-1172041 An alternate site burn occurred at the left corner of the patient's mouth during a tonsillectomy.
COVIDEN LAB, Brand name: Electrosurgical pencil Model# 145136, Lot# 146503 Using general anesthesia via mask, about 1 minute into procedure flames under drapes at right side of face while using cautery. Cause 2nd degree burn to pt face
VALLEYLAB, Device#1: Brand name: Force FX, Type of device: ESU, Device #2: Brand name: Ligasure, Type of device: ESU vessel sealing Device#1: Model# Force FX, Device#2: Model# LigasurePatient undergoing resection of large liver tumor. After surgery, patient had two burns on the left shoulder and back approximately 7 cm in diameter which required surgical debridement and flap closure.


Additional Information:

[1] CFR – Code of Federal Regulations Title 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=878.4400

[2] FDA MedSun Database
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm127686.htm

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Updated July 1, 2009

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