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U.S. Department of Health and Human Services

MedSun: Newsletter #34, March 2009

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Newsletter #34, March 2009

Articles

A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population

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By: Haynes, AB; et al.
The New England Journal of Medicine

Abstract

Background: Surgery has become an integral part of global health care, with an estimated 234 million operations performed yearly. Surgical complications are common and often preventable. We hypothesized that a program to implement a 19-item surgical safety checklist designed to improve team communication and consistency of care would reduce complications and deaths associated with surgery.

Methods: Between October 2007 and September 2008, eight hospitals in eight cities (Toronto, Canada; New Delhi, India; Amman, Jordan; Auckland, New Zealand; Manila, Philippines; Ifakara, Tanzania; London, England; and Seattle, WA) representing a variety of economic circumstances and diverse populations of patients participated in the World Health Organization's Safe Surgery Saves Lives program. We prospectively collected data on clinical processes and outcomes from 3733 consecutively enrolled patients 16 years of age or older who were undergoing noncardiac surgery. We subsequently collected data on 3955 consecutively enrolled patients after the introduction of the Surgical Safety Checklist. The primary end point was the rate of complications, including death, during hospitalization within the first 30 days after the operation.

Results: The rate of death was 1.5% before the checklist was introduced and declined to 0.8% afterward (P=0.003). Inpatient complications occurred in 11.0% of patients at baseline and in 7.0% after introduction of the checklist (P<0.001).

Conclusions: Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals.

Additional Information:

A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. Haynes, AB; et al. The New England Journal of Medicine. January 29, 2009.
http://content.nejm.org/cgi/content/full/360/5/491

World Health Organization (WHO) Surgical Safety Checklist. Supplementary Appendix.
http://content.nejm.org/cgi/data/NEJMsa0810119/DC1/1

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Syringe Reuse Among Infection Control Lapses Leading to 33 Outbreaks

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Forty outbreaks in hospital and non-hospital settings are examined in a recent study by the Centers for Disease Control and Prevention (CDC). This number is likely an under-representation, as test results and epidemiologic information were not always available. The CDC review emphasizes the need for more education specifically related to aseptic technique in injection safety, review of practices and training, and implementation of a consistent oversight in preventing the transmission of bloodborne pathogens in healthcare settings.

Additional Information:

Syringe Reuse Among Infection Control Lapses Leading to 33 Outbreaks. SafetyShare newsletter, Premier, Inc. January 27, 2009.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/01-09-full-txt.jsp#story-01

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Handoffs causing patient harm: A survey of medical and surgical house staff

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PubMed
By: Kitch BT, Cooper JB, Zapol WM, Marder JE, Karson A, Hutter M, Campbell EG.

BACKGROUND: Communication lapses at the time of patient handoffs are believed to be common, and yet the frequency with which patients are harmed as a result of problematic handoffs is unknown. Resident physicians were surveyed about their hand-off-practices and the frequency with which they perceive problems with handoffs lead to patient harm.

METHODS: A survey was conducted in 2006 of all resident physicians in internal medicine and general surgery at Massachusetts General Hospital (MGH) concerning the quality and effects of handoffs during their most recent inpatient rotations. Surveys were sent to 238 eligible residents; 161 responses were obtained (response rate, 67.6%).

RESULTS: Fifty-nine percent of residents reported that one or more patients had been harmed during their most recent clinical rotation because of problematic handoffs, and 12% reported that this harm had been major. Overall quality of handoffs was reported to be fair or poor by 31% of residents. A minority of residents (26%) reported that handoffs usually or always took place in a quiet setting, and 37% reported that one or more interruptions during the receipt of handoffs occurred either most of the time or always.

DISCUSSION: Although handoffs have long been recognized as potentially hazardous, further scrutiny of handoffs has followed recent reports that handoffs are often marked by missing, incomplete, or inaccurate information and are associated with adverse events. In this study, reports of harm to patients from problematic handoffs were common among residents in internal medicine and general surgery. Many best-practice recommendations for handoffs are not observed, although the extent to which improvement of these practices could reduce patient harm is not known. MGH has recently launched a handoff-safety educational program, along with other interventions designed to improve the safety and effectiveness of handoffs, for its house staff and clinical leadership.

For additional information, visit PubMed, a service of the U.S. National Library of Medicine and the National Institutes of Health.

Also visit December 2008’s Premier Inc. SafetyShare Newsletter for a summation of this study. You will find a direct link in Additional Information below.

Additional Information:

Handoffs causing patient harm: a survey of medical and surgical house staff. Kitch BT, Cooper JB, Zapol WM, Marder JE, Karson A, Hutter M, Campbell EG. PubMed. October 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18947116

Handoffs a Significant Source of Patient Harm; Interruptions and Noise Prevent Communication of Crucial Information. SafetyShare Newsletter, Premier, Inc. December 2008.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/12-08-full-txt.jsp#story-02

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Surgical Site Markers: Putting Your Mark on Patient Safety

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Pennsylvania Patient Safety Authority

A surgical site mark should not be easily removed with skin preparation but should not be so permanent that it last weeks or months after the surgical procedure. The results of three studies were inconclusive in determining the best performance of marks on skin when used with skin prep solutions. Healthcare facilities may want to conduct their own studies of surgical site markers and/or skin prep solutions to determine performance.

MedSun has received reports describing similar issues with pre-surgical markers. To view these reports, see link under Addition Information below.

Additional Information:

Surgical Site Markers: Putting Your Mark on Patient Safety. Pennsylvania Patient Safety Authority. December 2008.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2008/Dec5(4)/Pages/130.aspx

MedSun Reports. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D%5F6%27%2FD%20%0A

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LabNet

ISO Accreditation Comes to America: Are Labs Ready to Embrace an International Quality Management System?

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By: Malone, Bill
American Association of Clinical Chemistry (AACC)
Clinical Laboratory News

The College of American Pathologists (CAP) recently rolled out an optional accreditation program based on the ISO 15189 standard for medical labs. The primary benefit of using ISO standards comes from following its comprehensive and highly structured approach for quality management, while also allowing labs to employ tools like Lean or Six Sigma. However, CMS is not ready to make ISO standards a required part of lab accreditation under CLIA.

Additional Information:

ISO Accreditation Comes to America: Are Labs Ready to Embrace an International Quality Management System? Malone, Bill. American Association of Clinical Chemistry (AACC), Clinical Laboratory News. January 2009.
http://www.aacc.org/publications/cln/2009/january/Pages/CovStory1Jan09.aspx

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Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis

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Centers for Disease Control and Prevention (CDC) MMWR Report

The CDC's updated recommendation says that nucleic acid amplification (NAA) testing should be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB for whom a diagnosis of TB is being considered but has not yet been established, and for whom the test result would alter case management or TB control activities. However, culture remains the gold standard for laboratory confirmation of TB and is required for isolating bacteria for drug-susceptibility testing and genotyping.

Additional Information:

Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis. Centers for Disease Control and Prevention (CDC) MMWR Report. January 16, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm?s_cid=mm5801a3_e

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HomeNet

Medical Device Recalls - Hill-Rom 70 Semi-Electric Bed (Class 2 Recall)

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Recall posted on FDA website

Date Recall Initiated November 11, 2008

Date Posted January 16, 2009

Recall Number Z-0506-2009

Product Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.

Code Information Serial numbers HC100001 through HC101261.

Recalling Firm/Manufacturer
Hill-Rom, Inc.
125 E Pearl St
Batesville , Indiana 47006

For Addition Information Contact
Steven S. Hollingsworth
812-934-6727

Reason For Recall
Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed. For further information, please contact Hill-Rom, Inc. at 800-445-3720.

Action
Consignees were notified of the problem by letter dated 11/11/08 and instructed to position the bed at least 3 inches above the lowest bed position in order to prevent the problem, and then to only use the pendant electronic controls to raise and lower the head and foot sections of the bed, until Hill-Rom can repair the bed. The letter was entitled "Urgent Medical Device Correction.".

Quantity in Commerce 567

Distribution Nationwide.

Additional Information:

Hill-Rom 70 Semi-Electric Bed Recall. FDA Recall. November 11, 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=74910

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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 December 1 through December 31. 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:Tubing, Insufflation, Heated
Manufacturer: Stryker Endoscopy
Brand: Pneumo Sure
Model #: REF 620-040-690
Lot #: 060308D

Problem:

OR staff report that the insufflator blew apart where the device screws into the port at the machine side. The connection that goes into the insufflation machine itself literally blew apart with force. Staff report that this has happened several times in the recent past and that they have been reporting this and each event to the rep. Patient and staff were not harmed.

See picture of damaged insufflator.

photo image of damaged insufflator

Device:Bag, Foley
Manufacturer: C.R. Bard
Model #: 153202

Problem:

Bard Latex-Free 200ml urine meter with bag and Bard EZ-Lok Sampling Port, Ref#153202, and lot number unknown had to be changed by RN twice in twenty-four hours because the plastic piece that dumps urine from the tubing into the urometer kept breaking. This causes urine to go directly into the drainage bag without first flowing into the urometer. Urine outputs then becomes inaccurate for the hour. After talking with other RN's, we discovered that this had been happening frequently with other patients, requiring that they also have a foley system change. BioMed opened new Bard urine meter with lot number NGSK0339 and discovered the same issue. The bent plastic piece had gone into the meter twice, and it fell off of the drain tube easily as if it was not glued on at all.
======================
Manufacturer response for Urine Meter, (brand not provided)
======================
Left a voicemail, but have not heard back yet.

ANESTHESIOLOGY

Device:Tube, Tracheostomy
Manufacturer: Cook, Inc.
Brand: Blue Rhino Tracheostomy Kit
Other #: 0882002231

Problem:

The tracheostomy tube at the point where the inner cannula fits in broke three days after insertion of the device. The trach was replaced without complications. The trach was replaced without complications. The exact lot number is not known, but the following four lot numbers were present in the facility at the time of the event (2097034, 2103336, 2155476 and 2072520).
======================
Manufacturer response for 8 PERC Shiley Trach, Shiley
======================
Manufacturer representative came to facility to evaluate device. There is not a definitive answer as to why this occurred at this point in time. A similar incident occurred in close proximity to this event involving an 8 DCT Shiley Trach that is part of the Blue Rhino kit (Cook product).

Device:Ventilator
Manufacturer: Covidien Nellcor
Brand: Nellcor
Model #: 840

Problem:

Nellcor 840 ventilator alarm sounded and panel screen went black. Patient was immediately manually ventilated. The ventilator was turned off then back on but the panel screen remained black but all level alarms and lights remained on. The ventilator was exchanged for another ventilator and taken out of service. BioMed reported the cause of the ventilator failure was due to a CPU failure.

Device:Tube, Tracheostomy
Manufacturer: Cook Medical
Brand: Blue Rhino Kit
Cat #: 8DCT
Other #: 0807002123

Problem:

The white tip on the trach was found broken causing the inner cannula to not stay in place. The trach had been placed one day prior to this occurring. The trach was replaced without complication. This trach is a component of the Cook Blue Rhino Kit. A similar incident occurred a few days later involving a 8PERC Shiley trach. The exact lot number is not known, however, these two lot numbers were in the facility at the time of this incident (0808001639 and 0801000384).
======================
Manufacturer response for 8DCT Shiley Trach, Shiley Trach
======================
The manufacturer rep came to the facility and evaluated incident, a similar incident occurred a few days later involving a Shiley 8PERC trach. There is no known cause at this point in time.

Device 1:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 2:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 3:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 4:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Problem:

During a scheduled Preventive Maintenance inspection, it was noticed that there was rust on the Rod of the Bag/Vent Switch assembly. The assembly was replaced with a new part.
======================
Manufacturer response for Anesthesia Machines, Anesthesia Machines
======================
GE acknowledges that there is a problem, and are in the process of sending us an official letter, after their analysis and investigation is complete. The presence of Chloride in their manufacturing process, either during machining or cutting is contaminating the parts causing them to rust. They initially were using stainless steel grade 303 and switched to stainless steel grade 313.

Device:Ventilator
Manufacturer: Drager Medical
Brand: Drager Evita Xl
Model #: Evita XL

Problem:

There was a power surge and after the surge a loud high pitched squeal was heard. The monitor on the ventilator went black and did not work. The room smelled smoky, but no smoke was witnessed. The monitor was also hot to touch. Patient was bagged and a new ventilator was placed on the patient.
======================
Manufacturer response for Ventilator, Drager Evita XL
======================
Nothing as yet


GENERAL AND PLASTIC SURGERY

Device:Headrest, Or
Manufacturer: Orthopedic Systems, Inc.
Brand: Gentletouch 7" Headrest Pillow With Right Intubation Slot
Model #: 1937

Problem:

A patient underwent a cervical lymph node biopsy. She was in a prone position with her face in a foam headrest. The procedure was done under monitored anesthesia care. A flash fire occurred.

Unbeknownst to the healthcare provider team, the headrest device may act like a sponge to absorb and trap oxygen. It appears to have acted as a fuel source in a fire triangle.

Device 1:

Device:Cable, Reusable, Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: 22080116
Cat #: E9F20J002

Device 2:

Device:Cable, Reusable, Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: 22080033
Cat #: E9F20J029

Device 3:

Device:Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: E4M36M
Cat #: ACE36E

Device 4:

Device:Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: E4M73E
Cat #: ACE23E

Problem:

Harmonic Cord and open handpiece kept cutting off while cutting out the gallbladder. Handpiece and cord did not start doing this until after they cleaned the tip of the handpiece off. Kept giving Error code 5 "instrument". Changed handpiece and cord. It worked fine for a few minutes, then error code 5 and the code for handpiece temperature kept coming up.

Ethicon sales Representative tested the devices, along with the technical support people at Ethicon Endo-Surgery that were called on the phone. The actual same devices were used to perform this test, Problem could not be duplicated.

Ethicon was able to verify the errors stored in memory.
1- Error 1 is due to tissue stuck on the tip of the device.
2- Error 5 is a connection loose error between the handpiece single-use device and the cable.
3- The two cables were verified and checked, one had been used around 27 times and the other was used 15 times. Per manufacturer's guidelines, these cables should last well over 100 times.

The unit was returned back to service. The disposables will be shipped back to Ethicon Endo-Surgery Company, for further evaluation.

Device:Stapler, Linear Cutter, Surgical
Manufacturer: Ethicon Endo-Surgery, Inc
Brand: Endopath 45
Lot #: E4LL1G
Cat #: ETS45

Problem:

The vascular endo GIA stapler was inserted through one of the previous ports and placed across the superior segmental branch and fired. Upon removal of the stapler, the proximal staple line was noted to be incomplete and significant bleeding occurred. There was significant blood loss; however the procedure was completed without further complication. This patient did receive Hespan and 3 units of RBCs intraop. Patient was discharged home 10 days post op. The blood loss did not appear to impact the length of stay as patient had other some issues with a chest tube that had some increased drainage, but this resolved by discharge.


GENERAL HOSPITAL

Device:Tubing, Iv
Manufacturer: Cardinal Health Medical Products & Services
Brand: Smartsite Infusion Set
Cat #: 2420-0007

Problem:

Medication found dripping on the floor from IV tubing. The tubing had a hole found in the region right below the blue top piece that sits in the actual pump. The tubing was replaced, there was no patient harm.

Device 1:

Device:Bed, Ac-powered Adjustable Hospital
Manufacturer: Stryker Medical
Brand: Bed
Model #: 3000

Device 2:

Device:Nurse Call System
Manufacturer: Hill-Rom Company, Inc.
Brand: Nurse Call Module
Model #: M52

Problem:

The patient was trying to move in the bed and lost her balance and slid out onto the floor. The nurse call alarm did not work and the patient was heard calling from the room. The patient had removed the non-skid socks earlier. RRT trauma and MD was called and no injuries were noted. The bed was checked by Biomed and this bed cannot be connected to the Hill-Rom nurse call system that is used on this floor, because of the type of communication cable connected to the bed. The bed was not connected to the nurse call system which would have alarmed through the nurse call system to notify the clinical staff that a fall had occurred. The bed and nurse call tested fine.

Device:Bed, Ac-powered Adjustable Hospital
Manufacturer: Stryker Medical
Brand: Stryker Zoom Bed

Problem:

Stryker beds were found to have an unstable weld along the frame. There was no event with a patient. Twenty-one beds were examined and all have this unstable frame.

Device:Infusion Pump
Manufacturer: B. Braun Medical, Inc.
Brand: Outlook 100
Model #: 13215

Problem:

This report is a continuation of several reports previously filed. Our facility had been having ongoing issues with our B. Braun Outlook 100 pumps losing their drug libraries. This causes our RN's to resort to manual programming of rates, etc. We had reported a total of 379 events (there are a total 440 pumps total at our facility). We were initially told it was a battery problem by B. Braun. Then, we were told it was a software glitch. B. Braun came to our facility in mid-October to upgrade all of our pumps to a newer version of software. We were optimistic this upgrade had fixed the problem. Unfortunately, it was reported this morning that we have had 7 pumps lose their drug libraries so far this week. We will be creating a tool to keep track of how many times this happens, or if there are any repeat offenders, etc. There have been no impacts on patients at this time. The pumps were removed from service, and sent to our Clinical Engineering department for reloading of software. I did confirm that the 7 pumps had all received the recent software upgrade.

Device:Incubator, Infant
Manufacturer: Draeger Medical
Brand: Caleo
Model #: Caleo

Problem:

During the annual preventive maintenance procedure the Biomed Department discovered an issue with the manufacturer's procedure for calibrating the oxygen; it is not accurate and the unit does not respond in accordance with the manufacturer's documentation on the testing. We could not tell if the units passed the oxygen calibration or not. That made us uneasy so we went to their technical support for help. Until several discussions with technical support and the local service representative, Drager was not convinced there was an issue. Now that their service rep is involved they are finally convinced they may have a software issue with the oxygen calibration required by their software annually, and also in their service manual.

Device:Wound Care Mattress
Manufacturer: Kinetic Concepts, Inc.
Brand: 1st Step Select
Model #: 40525C

Problem:

Reporter was informed in the morning that there had been a burn incident last week involving this unit, and to go check it out. Found that unit was still in use on patient. Warmer was in off position and filter was not clogged to cause over heating of unit. Hoses at unit outlet were luke-warm and routed back around to the unit.

Met with Risk Mgr. Incident involved hoses on top of the mattress overlay which touched patient’s foot and caused a 1st degree blister burn.

They are to do an internal Root cause investigation and hold meeting to report findings. Met with Root cause committee and found that staff incorrectly used equipment, reporting process was not correct, and suspected equipment was not removed. Discussed corrective actions and remedies for Policies and Procedures.

The Staff had incorrectly routed the hoses on top of the foot board instead of around the end and bottom of the foot board, thus causing the hoses to be able to come into contact with the patient’s foot.

Once I was notified, I pulled the unit and ran the unit the way it was set at that time. Found the temperature to be at 103 degrees.
======================
Manufacturer response for Wound care Mattress, 1st Step Select
======================
Has never been heard of before. That it is unlikely to be attributive to the equipment in question.


MICROBIOLOGY

Device:Microbiology Culture Media
Manufacturer: Becton Dickinson
Brand: Thioglycollate Vitamin KAnd Hemin
Lot #: 8164953
Other #: product # 221788

Problem:

Gram stain results yielded gram positive beaded organisms on multiple specimens which were grounded using Thioglycollate. No organisms were seen when the same specimens were tested again without using Thioglycollate. The media was found to have high counts of nonviable organisms.
======================
Manufacturer response for Microbiology Culture Media, Thioglycollate Vitamin K and Hemin
======================
The response was that a Gram stain by itself can neither rule in or out infection since artifacts and non-viables may be present in the transport media. Most liquid media will have some level of microorganisms present in the product.

The batch history record was reviewed and was found to be satisfactory. There was no evidence of contamination in the retention sample. There was no evidence of contamination in the return sample.


CARDIOVASCULAR

Device 1:

Device:X-ray System, Cath/angio
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Axiom Artis

Device 2:

Device:Information Management System, Cardiovascular
Manufacturer: McKesson Information Solutions LLC
Brand: Horizon Cardiology

Problem:

Images from the Siemens Axiom Artis system are supposed to be archived automatically by the McKesson Horizon Cardiology Information system. Sometimes this does not happen. Departmental policy is that at the end of each case the monitoring tech is supposed to verify that the images have transferred over. Once the transfer and archiving is verified, the images can be deleted from the Siemens system.

In this case the team member noted that the images were missing, but didn't attempt to archive them. The team member then accidentally deleted the images from Siemens. Once deleted, these images can't be recovered. The cath procedure was re-done.

Device:Vascular Closure Device
Manufacturer: AccessClosure, Inc.
Brand: Mynx
Lot #: F0824904

Problem:

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 did have a palpable popliteal pulse or the right side post procedure and was transported to recovery in stable condition. Physician stated one of every two MYNX devices used are defective.

Device:Warming Cabinet
Manufacturer: Pedigo
Brand: Pedigo
Model #: P-2050

Problem:

Early this morning, a blanket warmer overheated (it was set to run at 160F). The blankets inside started to smolder and Plant Operations was called because of the odor. Apparently there was not enough smoke to trigger a smoke alarm. They removed power and then removed the warmer to an outdoor location to minimize the odor in the area. A plant operation's technician opened the door and the blankets flashed into flames. They quickly put out the flames and the fire department was not notified. The investigation into the cause of the fire leads us to believe that the blanket warmer was overfilled, thereby blocking the unit’s temperature sensor.

In talking with the manufacturer, we were informed that a new base was available for the unit. The new base reduces the likelihood of blankets overheating because it allows for extra distance between the bottom of the cabinet and the heating element. The manufacturer also recommended no more than 90 blankets be placed in the unit, and that the blankets should be rotated. Loading blankets at the top and removing from the bottom. This would allow the top blankets more time to warm and keep blankets on the bottom from drying out.

Device:Graft, Vascular
Manufacturer: Intervascular, SAS
Brand: Intergard Knitted Polyester
Model #: IGK0008-20
Lot #: 08F12

Problem:

Patient had 25-50% survivability prior to procedure due to extreme poor health. OR Procedure ECMO Insertion with cannulation by Cardiac Surgeon. Femoral graft attempted but there was severe bleeding (18 units in 1 hr at body of graft not anastomosis). A different graft was then placed in axillary artery with coagulopathy. Surgeon states used this graft for 2 years and that this one was defective. It is not clear what led to the massive bleeding but considering the amount of bleeding that occurred, there is legitimate suspicion that the weave might have been loose.

Device 1:

Device:System, Ecg Analysis
Manufacturer: GE Medical Systems
Brand: Case P2 Ekg Stress System
Model #: CASE P2
Other #: AS06571

Device 2:

Device:Treadmill
Manufacturer: GE Medical Systems Information Technologies
Brand: T2100
Model #: T2100
Other #: AS06574

Problem:

The patient was in the midst of a sestamibi treadmill stress test. During the test the patient had issues with frequent ectopy that were being closely monitored. When the patient got close to peak exercise, the monitoring system and treadmill froze, losing the ability to monitor this patient at a time when he was experiencing significant ectopy. Though the patient did not fall when the treadmill belt froze, we are concerned this could happen should this problem recur. We have had one prior occurrence of this problem in the past.


RADIOLOGY

Device:X-ray Unit, Mini C-arm, Portable
Manufacturer: GE OEC Medical Systems
Brand: Mini View
Model #: 6800

Problem:

Mini C-arm malfunctioned during a case; unable to shoot live films. Field Service Engineer replaced defective monitor. The monitor in this C-arm had also been replaced approximately one year earlier by the company. I talked to the GE Field Service Engineer briefly and he mentioned it seemed that those particular monitors were failing more often than he expected they should. He did not indicate that GE/OEC had a known problem with these monitors.

Device:X-ray Unit, C-arm, Portable
Manufacturer: Philips Medical Systems
Brand: Bv Pulsera
Model #: BV Pulsera

Problem:

In the OR the C-arm would not work. No X-ray and display has message "M379 Battery overcharge has enabled itself". Display also says "reset" next to one of the buttons. Pressed reset, C-arm resets and now can make X-rays. Looked for error message in manual, unable to locate it. Spoke with Philips service rep - he was unable to find info on the message and said to ignore it if it doesn't come back. Rebooted unit and message came back.

In a follow-up message, Philips states "Error indicates monthly battery deep cycle is running or needs to run, should clear after reset. Ok to use C-arm". Checked C-arm the next morning, re-booted unit and still getting M379 error. Philips service was called in to resolve the issue. Found out that setting the date forward 2 months and rebooting the unit will clear the error. Although M379 error is a known issue, it rarely occurs. The unit can be safely used until the error is cleared.

Device 1:

Device:Linear Accelerator
Manufacturer: Varian Medical Systems, Inc.
Brand: Clinac Linear Accelerator 2100 Ex

Problem:

Machine had been serviced several days before event. The physicist performed an IMRT (intensity modulated radiation therapy) quality assurance after service left. Quality assurance on the machine was not completed until he could review the plan the next day with the dosimetrist. After much consideration during the night, he called the next morning and requested that the dosimetrist monitor the first treatment of the day. The treatment was aborted on the first treatment field when MLC leaves did not move according to the patient's plan. Other treatments were simulated on the machine and nonstandard performance was again noted. The equipment was removed from service until vendor service was completed. Physicist performed checks on the machine and all IMRT/Forward Plans before resuming treatments. The machine was down two days.

Final response was not received from the manufacturer until several months later and it included the following information: The failure of a signal that communicates between the MLC and the Beam Gating PCB allowed the Beam to continue while the Step and Shoot field was changing from one field to another/broken or defective contact. In considering the worst case clinical scenario, it is assumed that only one field would receive treatment in this manner before a clinical user would notice that a beam hold is not asserted when the MLC leaves are moving. Step and Shoot treatments are typically the only type dynamic modality delivered at a site, and clinical users are accustomed to hearing the change of the audible beam tone from on to off when the beam hold is asserted: the failure of this change in tone would be apparent. Severity Rationale: Portions of critical structures may receive some dose while the expectation is that the beam has been held (turned off temporarily) to prevent dose from being delivered to critical structures. The planned dose targets would receive slightly lower dose, equal to the dose that had been incorrectly delivered during the prior step segment that should have been delivered during the shoot segment. Probability of harm rationale: the user can hear the Beam On Tone relevant to radiation being gated on and off. The presence and absence of the Beam On tone during high repetition rates is highly detectable. All users, typically a team, would have to not notice this situation. It will be obvious to those monitoring the treatment to notice the beam control was not working correctly due to their familiarity of this treatment type.


CLINICAL CHEMISTRY

Device 1:

Device:Analyzer, Chemistry
Manufacturer: Siemens Medical Solutions Diagnostics
Brand: Immulite 2000
Model #: Immulite 2000

Problem:

After being notified by an Endocrinologist that one of their patients had "unusual" results for Free T4 and TSH, we repeated the tests on the original sample in question the next day and found that the originally reported results were incorrect. The physician was notified of the corrected results. During further investigation we found nothing unusual about the samples. There were no related error messages on the Immulite 2000 instrument and no noticeable differences with anything at the time of repeating the tests. The instrument manufacturer's technical support was called the same day, but no immediate cause for the error was found. Technical support downloaded information from our instrument and told us that they would look into the matter. Two days later the technical service engineer relayed to the physician that there were numerous error messages contained in a log file that we should have been alerted to but were not. The engineer also found several parts that needed to be replaced and could have produced the erroneous results. These parts were replaced and additional quality control checks were performed. We are aware of only one patient that had unnecessary follow-up procedures started due to initial incorrect results.


OBSTETRICS/GYNECOLOGY

Device:Table, Obstetrical, Ac-powered
Manufacturer: BERCHTOLD Corporation
Brand: Operon D850 Multi-specialty Surgical Table
Model #: D850

Problem:

A gyn oncology fellow was trying to remove the leg portion of the bed to enable positioning pt. into lithotomy. The button that needs to be pressed to release the bed part was difficult to move, stuck, and not budging. As Doctor pressed the button, his finger got stuck in the metal latch under the gas cylinder of the bed piece.
======================
Manufacturer response for Multi-specialty surgical table, Multi-specialty surgical table
======================
Investigating. Checked out the table and found that when the doctor removed the head section that his right hand was under the gas cylinder. The lever must have been bumped causing the cylinder to release and pinch his fingers.


ORTHOPEDICS

Device:Implant, Acetabular Cup, Total Hip Replacement
Manufacturer: Zimmer, Inc.
Brand: Durom
Model #: 0100214150
Lot #: 2424625

Problem:

Patient admitted for revision right total hip replacement due to failed acetabular component. Indications: Patient clinical evidence for persisting weight bearing pain, right hip consistent with acetabular component loosening. Preoperative x-rays were satisfactory. Clinical experience indicated a strong suspicion of a microscopically loose acetabular component. There was no evidence of infection preoperatively. Findings: Consistent with microscopic loosening of a Durom 50-mm acetabular component metal on metal construct with a 44-mm inner diameter and a corresponding 44-mm diameter metallic head. No evidence of infection. Intraoperative gram stain negative for organisms or significant white cell count. She had a Durom system implant for treatment of osteoarthritis of her right hip. Her hip "never really got better." It became noticeably worse 2 months following surgery. She was having continued discomfort particularly navigating stairs. Eight weeks after surgery, she was still using crutches. X-rays at that time showed no change in the position of the construct including the cup. There were no loosenings noted.

Recall online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72743



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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Integra LifeSciences Corp.'s MAYFIELD Skull Clamp

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Over the past 2 years, MedSun has received 12 adverse event reports associated with the Mayfield Skull Clamp device manufactured by Integra LifeSciences Corporation. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold the head and neck in a particular position during surgical procedures. The reports were submitted by 6 hospitals between February 13, 2007 and February 13, 2009. The most frequently reported device problem was:

• Unintended movement or slippage of the skull clamp or pins

None of the reports involved a patient death. The patient injuries listed below were reported in 9 of these 12 reports.

• Laceration

All 9 of the reports that listed patient age had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 8 reports involved female patients and a total of 4 reports involved male patients.

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



MedSun Mayfield Skull Clamp Adverse Event Reports Received Between Feb 13, 2007 and Feb 13, 2009
Device Device Identifiers Event Description
Integra LifeSciences Corp. / MAYFIELD Headrest Device identifiers unknown Patient was placed on a Mayfield Headrest while on a stretcher. Patient was flipped onto OR bed and connected to the base of the Mayfield Headrest. Once connected it would not stay locked onto the patient's head, and the patient suffered two 4-6 inch lacerations to scalp. Large amount of blood poured onto floor and patient then had to be flipped back onto stretcher. Wounds were sutured.
Integra LifeSciences Corp. / MAYFIELD Modified Skull Clamp with Skull Pins Device identifiers unknown During the prep stage, the patient was placed in Mayfield head holder by the neurosurgical resident. Left sided pin was tightened to a torque of 60 lbs. Patient was being positioned by the resident and the physician assistant, the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration, and notifications were sent out. C-clamp and pins for the Mayfield were replaced with another set. The c-clamp and pins were segregated. This was a loaner set in which the torque screws were located on the two pin holders as well as on the left side of the c-clamp. The neurological Director requested an extra staff member be available at the head of the table with the Anesthesiologist to prevent this event from recurring.
Integra LifeSciences Corp. / MAYFIELD Head Clamp Device identifiers unknown Partway through a laminectomy procedure, while holding the hand drill to make entrance holes for screws in posterior cervical spine, there was a "clunk" and the head/neck very obviously changed position. Shortly after, Anesthesia informed of new and significant blood loss from area of pins. Surgeon found large laceration at original pin site (single pin site) going through to skull and periosteum was removed. Another laceration, slightly less deep, was perpendicular to this. Lacerations were cleaned and sutured. Pin not found in original position and fully retracted. (Of note, this was a loaner clamp following the recent problem with our own Mayfield skull clamp.)
Integra LifeSciences Corp. / MAYFIELD A-1059 Head clamp holds three skull pins for stabilizing the head during neurosurgical procedures. On turning patient to prone position, one pin slipped and cut the patient's skin. The clamp was reapplied in different area of skull and patient was connected to bed attachment for securing patient head in proper position for surgery.
Integra LifeSciences Corp. / MAYFIELD 40A1059 Skull clamp placed by a resident intra-operatively caused a laceration of the skull.
Integra LifeSciences Corp. / MAYFIELD Skull Clamp A-1059 Surgeon placed skull clamp on patient's head. Patient then turned prone in preparation for surgery on cervical spine. Clamp was firmly attached to Mayfield base support which is firmly attached to the OR table. While head was being repositioned by surgeon the swivel lock appeared to become unlocked and patient's head fell downward with the bridge of his nose striking the crossbar of the skull clamp. This injury was superficial. The surgeon once again repositioned and re-secured the head but then the head was "spontaneously ejected" from the skull clamp, resulting in a deep 5cm laceration above the right ear. This required closure with skin staples.

Manufacturer response for Skull clamp/head support (per reporting facility):
The manufacturer acknowledged the device's inherent instability. They supplied us with a loaner clamp while they evaluate ours. They provided me with the instructions for use upon request. The IFU does state that "The direction of the single pin should point directly through the center point created by the centerlines of the patient's head with the pins on the two-pin side of the skull clamp being equidistant to single-pin line of direction to obtain the highest degree of stability."
Integra LifeSciences Corp. / MAYFIELD Models 1059 and A1072 A three cm laceration was noted on the patient’s left side of the scalp as the patient was being positioned for posterior cervical laminectomy. The Mayfield skull clamp (Integra 1059) was being applied by the Doctor with Mayfield disposable skull pins in place (Integra A1072). Packaging was discarded; lot #, expiration date unknown.

Laceration closed. New skull pins applied. Another Mayfield Skull Clamp used without incident. Original Mayfield Skull Clamp removed from the OR, to be sent to company for evaluation with the permission of Risk Management.
Integra LifeSciences Corp. / MAYFIELD 40A1059 The patient was scheduled for posterior cervical fusion.
At the end of the procedure, it was noted that the pin sites on the head had shifted. The left posterior pin site had a one inch tear. The laceration was sutured by the surgeon.
Integra LifeSciences Corp. / MAYFIELD Device identifiers unknown The patient was being positioned on OR table for anterior cervical fusion with horseshoe head holder. Surgeon felt that head holder moved as pressure was being applied. Circulating nursing did not observe any movement. No patient harm per surgeon. Device sent to manufacturer for evaluation.
Integra LifeSciences Corp. / MAYFIELD A-1059 Case was a craniotomy. Intraoperatively after application of Mayfield skull clamp it slipped out of position from the patient's head. Patient not injured and the appliance was replaced with another Mayfield skull clamp.
Integra LifeSciences Corp. / Integra MAYFIELD Skull Clamp 40A1059 After application of the head holder, it slipped twice causing two lacerations. The lacerations were stapled.
Integra LifeSciences Corp. /Mayfield Head Rest or Head Clamp A-1059Patient was undergoing AVM for Chiari Malformation when intraoperatively the resident heard and then saw pins on Mayfield pop out of patient's head. Resident secured head and new Mayfield head rest was brought to OR. The new Mayfield was positioned, patient assessed and the new Mayfield remained in place for remainder of surgery. Outcome is still open to sequelae due to intraoperative surgery halt.

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Summary of MedSun Reports Describing Adverse Events With "Harmonic Scalpel" Ultrasonic Surgical Instruments

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Over the past thirteen months, MedSun has received 41 adverse event reports associated with the "Harmonic Scalpel" ultrasonic surgical device manufactured by Ethicon Endo-Surgery (37), or these same devices as reprocessed by a third party (3), or used with a "robotic" surgical system (1). The reports were submitted by 27 hospitals between January 1, 2008 and February 4, 2009. The most frequently reported device problems were:

• General operational, effectiveness or usability problem (13)
• Overheating / melting of pad / tip (5)
• Break or detachment of component (16)
• Issue with reusable cable, generator or error messages (5)

Two (2) reports described heat from the device producing a patient burn – in one case, having left small marks on the patient’s neck and in the other case, leaving a mark on the patient’s liver. Among the 16 reports in which a fragment, or component of the device is reported as having detached or broken off, there were only 2 instances in which the fragment could not be located and removed. In the other reports, the fragments were either located and retrieved surgically, or were described as having fallen off outside the patient. The patient problems were described most commonly as:

• Patient “burn” or other injury (2)
• Fragment could not be removed (2)
• Fragment removed surgically (5)

Of the reports that listed patient age, 2 had a patient age listed as less than 21 years and 35 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 32 reports involved female patients and a total of 6 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. The FDA appreciates your continuing to provide us with information about your experience with these devices.


[Note: The reports have been edited for clarity]



“Harmonic Scalpel” Ultrasonic Surgical Instruments
Device Device Identifiers Event Description
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E9FR2C Harmonic ACE scalpel being used. Surgeon states is "snagging". Replaced equipment immediately no harm to the patient surgeon requested to have it looked at.
Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Coagulating Shears Ethicon Catalog LCSC5HA Lot 149333 The products caused an error code #5 that could not be resolved in spite of trying to fix per instructions. Devices are reprocessed. No patient injury. This happened with two products - ACE Scalpel and Coagulating shears.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E4MEAZ Harmonic ACE curved shears received pad damage during intraoperative use - appeared melted. Surgery was laparoscopic supra-cervical hysterectomy. The sales rep was present and took the damaged product.

Clinical Engineering was called by the OR and informed that the return plate of the disposable shears had been damaged during the case. There wasn't any harm, but they wanted the device checked to make sure it is working properly. The salesman took the damaged disposable. He retrieved all 4 hand controllers because there wasn't any indication as to which was used. Completed safety and functional tests of the generator as per manufacturer's specifications. Completed functional test on hand controllers. Phase Margin (Hz)range should be between 170-247. Impedance (Zr) range should be between 15 - 40. No issues identified. All hand controllers were operating within tolerance. Clinical Engineering called the Ethicon sales rep. He explained that the incident was caused by the hand controller being activated after the shears had cut through tissue causing both sides to touch. If this happens throughout the case it could have caused damage to the return plate.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot Unknown Piece of harmonic scalpel broke off during procedure. Retrieved and bagged.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E4L98T (2 devices reported) I came to the OR because the instrument was stuck in the trocar and resident had to pull the trocar out to get the Harmonic ACE out of the patient. The instrument was stuck in the trocar. The resident stated that the instrument went in fine but was unable to pull it out of the trocar, so trocar was removed also. They opened another Harmonic ACE and an 8mm trocar. The instrument and trocar were handed off the sterile field. I saw that the rep was here and contacted them to come to the OR. She stated that the Harmonic ACE does fit inside the 5mm Xcel trocar and didn't understand why this had happened. The rep pulled very hard on instrument to get it out. Then the instrument slid in and out of trocar without an problem. Another Harmonic ACE was opened. (Also an ACE36E) This one was given back to me because the rep told me the harmonic pad was burned out on it. No harm to patient on either issue. Just inconvenience. A third Harmonic ACE was opened for case. Surgery then continued.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4MC3T Harmonic tip was being cleaned by scrub when plastic pad was dislodged. Cleaning tip is routine. Device replaced with new device and procedure continued. No harm to patient.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4MC3J During a Laparoscopic Supracervical Hysterectomy, a harmonic ACE36E was being used. The M.D. noticed that it was not working as well as prior. The device was removed and noticed the white pad covering the foot plate was melted and loosely hanging on. This was discarded and a new device was used. No apparent harm was noted and the case was completed
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E4ME93 Harmonic Ace teflon tip became loose and broke off. It was removed from service. The defective equipment was saved for return to vendor.
Ethicon Endo-Surgery, Inc. Harmonic Shears and Handpiece Cable Harmonic ACE Cable Catalog< 22080116 Lots E9F20J002 and E9F20J029, Harmonic ACE Shears Catalog ACE36E Lots E4M36M and E4M73E/TD> Harmonic Cord and open handpiece kept cutting off while cutting out the gallbladder. Handpiece and cord did not start doing this until after they cleaned the tip of the handpiece off. Kept giving Error code 5 "instrument". Changed handpiece and cord. It worked fine for a few minutes, then error code 5 and the code for handpiece temperature kept coming up. Ethicon sales Representative, tested the devices, along with the technical support people at Ethicon Endo-Surgery that were called on the phone. The actual same devices were used to perform this test, Problem could not be duplicated. Ethicon was able to verify the errors stored in memory. 1- Error 1 is due to tissue stuck on the tip of the device. 2-Error 5 is a connection loose error between the handpiece single-use device and the cable. 3- The two cables were verified and checked, one had been used around 27 times and the other was used 15 times. Per manufacturer's guidelines, these cables should last well over 100 times. The unit was returned back to service. The disposables will be shipped back to Ethicon Endo-Surgery company, for further evaluation.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot E4KE6T While using the ACE harmonic instrument the machine made a noise and the instrument itself was making a noise and the instrument would not work when foot pedal touched, while detatching the instrument from the handle one side of the open forcep fell off.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot E41840 The left ovarian vessels were grasped and coagulated and transected. However, there were some issues I felt with the Ace Harmonic. It did not feel like it was grasping adequately or transecting the way it should, so we traded this out for another one. At this point, we had Patient in OR for laparoscopic total hysterectomy, left salpingo-oophorectomy, resection of pelvic peritoneal lesions/ endometriosis. Excellent performance of the equipment and the left pedicle was once again re-coagulated with excellent assurance and control. The round ligament was grasped, coagulated, and transected. No harm to patient.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lots E4MD0Z and E4ME6H Harmonic scalpel tested okay and ready for use. Ten minutes into case, machine alarmed and handpiece was pulled out of pt. Jaw of handpiece was loose and charred. Handpiece was changed, tested okay and ready for use. The same thing happened to the second handpiece: machine alarmed, handpiece jaw was loose and charred, melted tip of the port sleeve. Machine taken out of service by Biomed. Cord was tagged and reported to SPD. No injury noted to patient. Machine checked by Biomed and Ethicon rep. was notified.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4MF32 The jaws on the Harmonic Scalpel "melted" during use. They appear dark and discolored at this time, as if they were burnt.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4L39K Harmonic scalpel being used during lap assisted splenectomy when it was noted the small "white pad" on the shear portion of the harmonic scalpel came off. Fortunately this was visually noted at time of occurrence and "pad" was able to be retrieved by surgeon.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4M648 Harmonic handpiece would not function regardless of what type of tissue was in the jaws. It repeatedly errored and went to standby. We opened another handpiece and proceeded without further issue. No harm to patient.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36E Lot E4MC3J Harmonic would function properly when jaws were open but would not work when jaws were closed. No harm to patient.
Ethicon Endo-Surgery, Inc. Ultracision Harmonic Scalpel Catalog, Model or Lot not given The handpiece stopped functioning while it was in use on the patient. The Harmonic Generator was turned off and on to reset the new handpiece, tested, and the case proceeded without incident.

The Harmonic Generator was tested and found to be functioning appropriately.
No patient harm.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot Unknown (2 devices reported), Catalog ACE36E (2 devices reported) Lot EHLX5F and other lot unknown During use of Ethicon disposable Harmonic ACE handpieces, devices break in use and/or pieces fall off inside patient. Multiple devices fail during one case:

Patient 1: During operative procedure (LSH) Laparoscopic Supracervical Hysterectomy, staff noticed the metal blade was broken off. They removed the harmonic scalpal ACE36P and retrieved the broken metal tip out of the patient's abdomen. Opened a second device and used for approximately 1-2 minutes and then it quit. Upon removing the second device and placing on the Mayo stand, the metal tip fell off. Opened a third device to finish the case. Placed the third device on back table and the metal tip broke off onto the table.

Patient 2: During operation procedure (LSH) Laparoscopic Supracervical Hysterectomy, physician was using harmonic scalpel ACE36P when staff noticed white pad was missing off disposable device. Harmonic scalpel was removed and pad was retrieved from patient's abdomen. A second handpiece was opened and the case completed.

Patient 3: During LSH procedure (Laparoscopic Supracervical Hysterectomy), physician was using Harmonic Ace when staff noticed the pad was partially off the disposable handpiece. Device was removed and another handpiece was opened. Surgery was completed.

Patient 4: During surgical procedure (LSH) Laparoscopic Supracervical Hysterectomy, white pad on device became loosened, but still attached. Surgeon requested another device. Second handle opened and case completed.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E4L08E Harmonic Scalpel giving us problems - kept faulting to ERROR CODE 5 INSTRUMENT. We tried taking it apart and putting the handpiece back together, cleaning the tips often,and tightening the handpiece again with the wrench. The circulator could not leave the machine because she had to keep hitting STANDBY to make it work. The representative was called and he could not fix it on the phone. The representative was on his way in, but it would be a hour before he could get to the hospital. Since the doctor was in the middle of the actual resection, he elected to get another type of device to finish the resection. Biomed was paged to look at the equipment.
Intuitive Surgical, Inc. DaVinci Harmonic Curved Shears DaVinci Catalog 400169-06 Lot C8066Patient undergoing robotic assisted total laparoscopic hysterectomy. The harmonic curved shears were inserted into the trocar and prior to the machine being hooked up or used, the surgeon noticed that part of the tip was missing. This was a disposable item that had not been used yet in the case. The device was not broken when removed from packaging. The surgeon was able to find the rest of the tip and removed it from the patient. There was no harm to the patient.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36E Lot E4LR14 During a Lap Nephrectomy part of the Harmonic Ace broke off. Delayed surgery to look for missing piece and do X-rays. The piece they were looking for was later found on the floor.
Ethicon Endo-Surgery, Inc. Harmonic Scalpel Harmonic FOCUS No other identifiers provided The hand piece of the harmonic scalpel failed to work appropriately. The white insert on the jaws of the instrument slides up and down. This is not normal for this device.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Ultracision Harmonic Scalpel P/N P30108P14 Lot C9D58U Staff were setting up the operating room for a case. They opened the device and tested it before use. They could not get the device to work. They tried a disposable cord also and the device wouldn't work.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shear Harmonic FOCUS Catalog FCS9 Lot ERK49M and D4JP12 Surgeon was performing a total thyroidectomy and parathyroid exploration using the harmonic scalpel. It was reported that the harmonic focus handpiece became very hot. REF FCS9. It was also noted that on at least one occassion this device had burnt through the surgeons gown as well as leaving small marks on the patient's neck due to the heat of this handpiece. Staff had also noted on five other occassions the device to not work as intended. These devices were placed in the nurse managers office for handling. However, staff did not provide any patient identifiers or specific product identifiers other than the device themselves. One other lot number was identified to have been one of the five other devices. It is lot number D4JP12.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE No other identifiers provided. After using the harmonic scalpel, it started to alarm and would not work.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot EAK38T Patient was undergoing a left laparoscopic hand-assisted donor nephrectomy. Retractor was placed under the tip of the 12th rib, the camera through the upper port, and harmonic scalpel through the lower port and the left lower quadrant, and dissection was begun. Plastic platform from the harmonic scalpel came off sometime during the operation. The plastic piece was the size of a staple. The surgeon felt it was no different than a surgical clip, therefore, it was decided that further surgical intervention to retrieve the plastic piece was not warranted. Otherwise the surgical procedure was completed without further incident and/or untoward effects
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Model LCSC5HA Lot Unknown After opening the device during the testing portion with the 5mm hand-activated curved shears Harmonic scalpel (model LCSC5HA), the hand activation piece failed. The machine worked, as did the foot pedal, but the hand activation buttons would not test or work. A new scalpel was opened, which worked fine.
Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Shears Ethicon Catalog ACE23P Lot 160687 The white plastic tip inside the Ethicon ACE23P harmonic scalpel jaw came off during surgery. The location of the tip after coming off could not be determined. Although the device is manufactured by another manufacturer, the problem may have stemmed from reprocessing done by Ascent Healthcare Solutions. Ascent has requested the ability to come examine the device, which we will allow them to do.
Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Shears Ethicon Catalog ACE36P Lot 161046 The 36cm long Ascent Harmonic ACE scalpel was used one time and then it would not work again. This device passed the self test prior to use. The catalog and lot numbers for this device were ACE36P and 161406 respectively.
Ethicon Endo-Surgery, Inc. Harmonic Scalpel Harmonic Instrument, Only Lot # E4KX6V and E4L352 provided Device worked briefly (approximately 30 seconds) then would not work.
Ethicon Endo-Surgery, Inc. Harmonic Scissor Grip Harmonic ACE Catalog ACE14S Lot E4KZ24 The Harmonic scalpel would not work, it was noted that the screw at the base of the cord was sheared off, and the end appeared to be in the handpiece.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot E4KD53 or E4KP53 (lot # unclear) Doctor reported that when there was just a small remainder of the uterus to be transected on the right side, it was noticed that one blade of the harmonic scalpel had weakened and broken off. The blade did not break off in the patient's abdomen and was located on the drape. A new harmonic scalpel was obtained and procedure continued with no complications.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36P Lot E4KE3C Harmonic scalpel instrument did not work on minimum setting - only maximum setting using handpiece. Device worked on both minimum and maximum settings using foot pedal when tested at end of case. Manufacturer was called and notified of the incident.
Ethicon Endo-Surgery, Inc. Harmonic Scalpel Harmonic Scalpel Catalog LCSC5HA Lot E4K587 Harmonic scalpel was removed from the trocar and the tip broke off on the mayo stand. The piece was recovered and nothing was retained in the patient, since the tip broke after it was removed.
Ethicon Endo-Surgery, Inc. Harnmonic Scalpel Harmonic ACE No other identifiers provided The shaft of the harmonic ACE left a mark on the patient's liver. The device was not used again and removed from the surgical field.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot D4JT2J Patient admitted for outpatient surgery, laparoscopic bilateral salpingo-oophorectomy. During the procedure, the surgeon attempted to use the Harmonic Scalpel/Ace Curved Shears with Pistol handle and hand control. Equipment not working. Attempted to use another cord without success. Then used another disposable handpiece with success. At the end of the case, device placed in sink to clean and noticed one end of the shears missing. Surgeon notified. X-ray completed in PACU which was read to be free of foreign object per Radiologist and Surgeon.
Ethicon Endo-Surgery, Inc. Harmonic Scalpel Catalog LCSC5L Lot D4JV05 During procedure, the disposable harmonic shears stopped cutting. The shears were rinsed and retested. Not cutting. The cord was tested - no failure detected. The generator was working fine. The shears were replaced with new ones, and the procedure continued without further incident.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36P Lot Unknown Jaw broke on device.
Ethicon Endo-Surgery, Inc. Harmonic Shears Harmonic ACE Catalog ACE36P Lot Unknown The tip of the reuseable harmonic handpiece broke off while using the ACE36P.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shears Harmonic ACE Catalog ACE36P Lot D4HG18 Harmonic scalpel did not pass test.
Ethicon Endo-Surgery, Inc. Harmonic Curved Shear Harmonic FOCUS Catalog FCS9 Lot D4J79H While the physician was using the Harmonic Curved Shears Scalpel with the Focus Handpiece, he/she noticed that the handpiece was burning the plastic on the tissue pads of the handpiece. Another handpiece was opened to finish the case. The manufacturer provided an RGA number for return and evaluation, and provided a shipping container.

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Updated March 1, 2009

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