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U.S. Department of Health and Human Services

MedSun: Newsletter #48, May 2010

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Newsletter #48, May 2010

Articles

Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall

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FDA MedWatch Safety Alert

This April 27, 2010 update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices' self tests on February 24, 2010 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices.

Read the complete FDA MedWatch 2010 Safety, which includes links to the original Class 1 recall notice posted March 8, 2010 as well as updated recommendations.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall. April 27, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205165.htm

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FDA Launches Initiative to Reduce Infusion Pump Risks

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FDA Press Release

The FDA announced a new initiative to address safety problems associated with external infusion pumps. There will also be a public workshop in May on infusion pump design. The Agency is also launching a new Web page devoted to infusion pump safety. The agency's new infusion pump safety Web page features basic information about infusion pumps and steps that patients and healthcare professionals can take to prevent and report safety problems, even before new or redesigned pumps are brought to the market.

Additional Information:

FDA Press Release. FDA Launches Initiative to Reduce Infusion Pump Risks. April 23, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209042.htm

FDA Center for Devices and Radiological Health. Infusion pumps website. April 26, 2010.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm

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Covidien Initiates Voluntary Recall of Certain Shiley Tracheostomy Tubes

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FDA MedWatch Safety Alert

FDA and Covidien notified healthcare professionals of a recall of certain lots of its cuffed Shiley TM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product's cuff not holding air as a result of leaks in the pilot balloon inflation assembly. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death. The voluntary recall only affects lot numbers from a specific period of time.

Additional Information:

FDA MedWatch Safety Alert. Covidien Initiates Voluntary Recall of Certain Shiley Tracheostomy Tubes. April 24, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209712.htm

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LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly, power off then on by itself, power off then not turn on, power off by itself requiring the operator to turn it back on, or stay powered on and not allow itself to be turned off.

Additional Information:

FDA MedWatch Safety Alert. LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc. April 22, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm

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LabNet

6 Safety Tips for Operating a Centrifuge

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Lab Manager Magazine

There are a few important guidelines for operating a centrifuge, even a small one. Following them can prevent damage to the centrifuge and possible serious injury to you and others. This article provides guidelines for operating a centrifuge.

Additional Information:

Lab Manager Magazine. 6 Safety Tips for Operating a Centrifuge. February 24, 2010.
http://www.labmanager.com/stips.asp?ID=105

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Lessons from the POCT Front

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AACC Clinical Laboratory News

As manufacturers, users, labs, and regulators collaborate to address POCT analytical issues, labs have an important role in managing expectations and clarifying appropriate usage of POCT devices. With the POCT market only expected to grow in coming years, solid lab-POCT site relationships will be essential to maintaining viable POCT services.

Additional Information:

AACC Clinical Laboratory News. Lessons from the POCT Front. March 2010.
http://www.aacc.org/publications/cln/2010/march/Pages/CoverStory1Mar2010.aspx

FDA/CDRH Public Meeting: Blood Glucose Meters - March 16-17, 2010.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm187406.htm

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Featured LabNet Report of Interest

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Your reports of actual adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and LabNet. The following event reported by a MedSun LabNet facility resulted in manufacturer action:

Type of Device: Chemistry Analyzer
Device Manufacturer’s Name: Beckman Coulter, Inc.
Date of this report: March 16, 2010
Model: DXC 600I
Product Name: UniCel DxC Synchron Clinical Systems

Reported Event: Incorrect sodium result released. A sodium result was reported as high at 151. The MD called the lab questioning the result. A repeat specimen obtained and was within the normal limits of 138. It was then discovered that there was an issue with the instrument and the initial result was corrected. There were a total of seven patients that had incorrect sodium results posted and then corrected that same day. The other six were outpatients that were corrected within 14 minutes to 3 hours and no patient care decisions were made on any of those patients. None of the patients had labs repeated. All the initial results that were high (149-153) were corrected with all results being within normal limits (136-141). The difference between the initial and corrected results ranged from 10 to 16 points. The lab had been complying with all recommendations and requirements related to maintenance of the electrode module that had been released over the past several months by Beckman and the FDA.

Related Recall: Please see the following Class 1 recall for this model (and others) of the Beckman Coulter UniCel DxC Synchron Clinical Systems. The reason for recall is excessive Buildup of protein, bacteria and sample tube additives in the ISE flow cell may cause erroneous NA (sodium) results. To read the FDA recall notice, see link provided under Addition Information below.

Additional Information:

Medical Device Recall. OneTouch Beckman Coulter UniCel DxC Synchron Clinical Systems Class I Recall. March 4, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88235

MedSun Report. March 16, 2010. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D7%3B%26%3FX%20%0A&CFID=38122874&CFTOKEN=5f9e788b9187ab99-01F85

FDA Patient Safety News (video) - Recall of UniCel DxC Clinical Analyzers. May 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=98#5

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HeartNet

MedSun Continues to Receive Reports About Unretrieved Device Fragments

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MedSun continues to receive cardiovascular-related event reports that describe issues with Unretrieved Device Fragments (UDFs).

On January 15, 2008 FDA notified Healthcare Practitioners to a Public Health Notification entitled, "FDA Public Health Notification: Unretrieved Device Fragments", which informs providers of serious adverse events associated with UDFs and provides recommendations to mitigate these events.

A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties. To view recent cardiovascular-related UDF reports submitted by MedSun facilities, see links under Addition Information below.

Additional Information:

MedSun Report. March 4, 2010. Available online.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D7%3C%27O%40%20%0A&CFID=36277908&CFTOKEN=af843cf573b3ec4-9BC134

MedSun Report. October 28, 2009. Available online.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2D3%3F%26%5FP%20%0A&CFID=36277908&CFTOKEN=af843cf573b3ec4-9BC134

FDA Public Health Notification: Unretrieved Device Fragments. FDA Medical Device Safety. January 15, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm

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HomeNet

FDA launches the Home Use Medical Device Initiative

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FDA Press Release

FDA announces the launch of the Home Use Medical Device Initiative. Through this initiative, FDA will take actions to support the safe use of medical devices in the home. To learn more about this effort, visit the FDA News Release, entitled, "FDA to Address Challenges of Using Complex Medical Devices in the Home."

Additional Information:

FDA News Release. FDA to Address Challenges of Using Complex Medical Devices in the Home. April 20, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm209138.htm

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FDA introduces new Home Use Device Website

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FDA's Home Use Device website provides resources and safety information about medical products used in the home environment. To see all that this new website has to offer, visit the Home Use Device website link below.

Additional Information:

FDA Home Use Device Website. April 20, 2010.
http://www.fda.gov/homeusedevices

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KidNet

Featured KidNet Report of Interest

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Your reports of actual adverse events, and more importantly, reports of 'potential for harm,' 'near miss,' and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and KidNet. Potential for harm, near miss and close calls may be related to human factors issues such as incomplete or confusing instructions for use, labeling that is too small to read or unable to be easily seen by the user, or device design, i.e., ‘double bouncing’ keys, or inaudible alarms. Events that don’t involve patients or caregivers directly are particularly valuable as they represent an opportunity to address a problem before an injury occurs.

The following event reported by a MedSun KidNet facility of a ‘potential for harm’ event resulted in manufacturer action:

Type of Device: Infant Warmer
Device Manufacturer’s Name: Draeger Medical Systems, Inc.
Date of this report: May 2, 2008

Reported Event: An infant warmer ignited while the unit was in the operating room pending delivery of the infant. The unit was in operation but the infant was not in the bed. A manufacturer’s representative came to the facility to replace parts on the damaged unit and will be replacing the heater elements on all units in the facility.

Related Recall:This event contributed to a Class 2 recall posted August 26, 2009 for the heater elements on Resuscitaire Infant Radiant model numbers RW82, RW82 VHA, WBR82, and WMRW82 - 120 volt configuration only - manufactured Draeger Medical Systems. The reason for this recall is a mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly. To read the FDA recall notice, see link provided under Addition Information below.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of MedSun or KidNet, or through your hospital’s reporting policy.

If you are not affiliated with a hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related adverse events a model for patient safety.

Additional Information:

Medical Device Recall. Class 2 Recall: Heater Elements for Resuscitaire Infant Radiant Warmers. August 26, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=84109.

MedSun Report. May 2, 2008. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%2D%5F%3C%26%5F%3C%20%0A

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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 February 1 through February 28 2010. 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.


CARDIOVASCULAR

Device:
Type: Monitor, Blood Pressure, Transducer
Manufacturer: Hospira
Brand: Hospira
Model #: 42647-06
Lot #: 78-442-5G (possible)
Cat #: 42647-06

Problem:
The Safeset tubing separated from the Safeset sampling port. This has happened about three times, but this is the first time Biomed was notified and the first time a sample of the defective product was returned.

According to the Biomed and healthcare provider, the impression was that whatever is supposed to seal the tubing to the port was not adequate and allowed the tubing to pull out easily. The manufacturer stated that there is an expected tension that can be tested so the defective set was sent back along with a new set.


Device:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: Hospira Global Medical Affairs
Brand: Multiflex
Lot #: 78-613-2A
Cat #: 41229-01

Problem:
Swan-Ganz catheter balloon avulsed off of catheter in removing catheter from the patient. Patient monitored closely. Catheter was given to biomedical engineering. Family and patient disclosed as well. Patient needs surgery (independent of this occurrence). Physician informed. Patient to be admitted; will continue to monitor.

See device images:

Swan-Ganz - catheter balloon avulsed off of catheter

Swan-Ganz - closer view of Swan-Ganz catheter balloon avulsed off of catheter

Swan-Ganz- Heparin coated catheter


Device:
Type: Lead, Pacemaker
Manufacturer: Boston Scientific
Brand: Dextrus
Model #: 4135-45 cm

Problem:
The physician attempted to insert the lead into the introducer and was unable to insert it. A 7-French peel-away sheath was used. The physician is very experienced with implanting leads and would like the lead sent back to Guidant as defective. The physician used another manufacturer's lead to complete the procedure. There were no problems with the patient outcome.


Device:
Type: Defibrillator, External
Manufacturer: Medtronic/Physio-Control Inc.
Brand: Lifepak 20
Model #: LP20
Other #: Battery for LP20, PN B11293, Unipower, NIMh, 3ah 12V

Problem:
We have approximately 206 LifePak 20's in our facility's inventory. We have reviewed all of the LifePak 20 work orders from the past year until now, and have seen that there is a power supply problem that is best described as: when turned on in the battery mode (not plugged into wall power) the LP 20 intermittently comes on for a second, then goes off. This problem has been identified during preventative maintenance checks. I have tracked these repairs on our internal work orders, and I am certain that Physio Control's work order system will also show this history since our Physio service rep has done all of the repairs.

I am sending this report because we consider this issue to be a serious problem. The fix for this always seems to be replacement of the Power Supply Board (PSB) which was confirmed by Physio. The software and PSB versions are unknown to us. We are quickly losing faith in the reliability of the LP20 due to this one repetitive problem. Our LP 20 fleet is approaching 6 years old, but I do not believe that it is the age that is causing this failure. We have had too many fail with this same symptom and same fix. The work order history shows me the following 8 occurrences with this specific complaint, and two more that seem similar which are included in this report. This is nearly 5%. This seems to us like a serious issue. No injuries have been reported.

Manufacturer response (as per reporter): an email was sent on the date of this report and we are waiting for a response.


NEUROLOGY

Device:
Type: Motor, Drill, Pneumatic
Manufacturer: Stryker Instruments, Instruments Division
Brand: Maestro Drill
Model #: 5400-200
Other #: Attachments: 5400-210-58; 5100-120-450; 5100-120-480; 5100-120-470; 5100-120; 5400-210-56; 5100-120-472
Problem:
Neurosurgeon was using MAESTRO Drill to turn cranial bone flap during craniotomy and tumor resection. Surgeon reported greenish/silverish fluid (which appeared to be oil) leaked out of the drill and appeared to drip into the surgical wound. Drill was immediately removed from surgical field. Wound irrigated copiously with polymyxin irrigation. The patient tolerated the procedure well and was discharged as planned on. She was recently seen in outpatient follow-up and appears to be doing well. The surgical wound appears to have healed without complication and the patient has remained afebrile. Next follow up in 3 months. The device was returned to the manufacturer for evaluation.


ANESTHESIOLOGY

Device:
Type: Intubating Lma (Rescue Airway Device)
Manufacturer: LMA North America, Inc.
Brand: Fastrach
Model #: REF 136079
Other #: P/N 3000351-1-02/05

Problem:
A patient's airway was protected using a Fastrach LMA (laryngeal mask airway). The device is an LMA that the anesthesiologist inserts then snakes an endotracheal tube (ETT) over to protect airway. Device is marketed to secure the airway during rescue and pre-hospital. Nowhere on the packaging does it say that the LMA contains metal and is therefore not MRI safe. Patient was taken into MRI scanner and scanned; his whole neck appeared to be full of metal. Airway exchanged to regular ETT and scan redone.


Device:
Type: Blood Conservation System
Manufacturer: Stryker Instruments, Instruments Division
Brand: Stryker
Model #: 225-28-916
Lot #: 09301012
Cat #: 225-28-916

Problem:
Staff state that there is new packaging for this product and sterility is compromised getting the product out of the outer package. This is the first time Biomed has been notified and received the product but staff says it has occurred 4 times. Product had to be discarded due to sterility being compromised trying to get the inner package out of the badly designed large outer wrap.

Manufacturer response (as per reporter): manufacturer is familiar with this complaint. Issued return number.

See device images:
Blood Conservation System Packaging - Back of Product in Outer Packaging

Blood Conservation System Packaging - Front of Product in Outer Packaging


Device:
Type: Side Air Port Connector
Manufacturer: Coopersurgical, Inc.
Brand: Inca Infant Nasal Cannulae Assembly For Cpap
Lot #: 82082, 81160
Other #: 10.5F

Problem:
An infant was placed on CPAP utilizing an infant nasal cannula assembly. The ventilator providing the CPAP alarmed "no flow"; airflow was occluded. When the setup was disassembled by the Respiratory Therapist to troubleshoot the problem, it was discovered that the hole on the side air port blue connector does not go all the way through. The manufacturer representative was notified and removed the defective devices the next day. Approximately two weeks later, two additional defective sets were discovered with a different lot number. Quality Management and the manufacturer representative were notified.


Device:
Type: Adult Ventilator
Manufacturer: MAQUET CRITICAL CARE AB
Brand: Maquet
Model #: Servo 300A

Problem:
Patient had been on Maquet Servo 300A ventilator for two days. Vent settings were 40% O2, pressure support +5, PEEP +5. The RT called asking for the oxygen sensor to be changed because it started reading 16% O2 and "O2 sensor out of range" alarm was activated.

The Asst Dir of CardioPulmonary checked the machine by decreasing the FiO2 to 21%. The ventilator would not cycle. When the FiO2 was put back at 40% the ventilator would cycle correctly. The ventilator was removed from service.

The Biomedical Engineering Technician found the air gas module was slightly pulled back from the connection, even with the retaining screw in place.

Manufacturer response (as per reporter): Since we have had that air gas module for seven months, they would not replace it.


Device:
Type: Mechanical Ventilator
Manufacturer: Covidien Puritan Bennett
Brand: Puritan Bennett 840
Model #: 840

Problem:
It is standard operating procedure at this institution to hard-wire connect all mechanical ventilators directly into the ICU central monitoring system for added overhead alarm annunciation within the ICU. This added alarm capability allows clinicians, within the ICU and outside of patient cubicles, to identify an audible and visual high priority ventilator alarm condition and directs them the appropriate bed space.

For 8 months, we have experienced a reoccurring issue, total of 28 in all, identifying the Covidien-Puritan Bennett 840 mechanical ventilators losing this connectivity with the patient ICU central monitoring system. This loss of communication results in a loss of the overhead ventilator alarm annunciation capability. The loss of connectivity is displayed on the screen of the cardiac monitor to alert clinicians. This condition does not affect the operation of the ventilator's internal alarm systems or the normal operation of the ventilator itself. There are 3 different types of ventilators utilized in this institution and only the Covidien-Puritan Bennett brand is having this issue. This loss of connectivity/communication can be re-established by removing the patient from the ventilator, providing manual ventilation and restarting the ventilator which effectively resets the connection.


Device:
Type: Endotracheal Tube Introducer
Manufacturer: Sun Med
Brand: Endotracheal Tube Introducer

Problem:
Anesthesia inserted ET tube and Endotracheal Tube Introducer "stylet" in OR. Approximately 3 1/2 hours later the patient coughed up a small blue plastic piece, thought to be from this device. Appears to have broken off at the curved tip. Approximately 1 inch broken off. Tip retained; stylet and original package not retained.

See device image:
ETT Blue Plastic Tip


Device:
Type: Mechanical Ventilator
Manufacturer: Covidien
Brand: Puritan Bennett 840
Model #: 840

Problem:
Patient had been on ventilator in Cath Lab. No issues noted. Patient was disconnected from vent for transport to ICU. Respiratory Therapist (RT) moved ventilator to ICU. The vent setting/set up was already programmed for patient as per use in Cath Lab. RT reconnected patient. Vent displayed code "WAITING FOR PATIENT CONNECT. Ventilation will begin when connection detected". Patient manually ventilated & another ventilator machine was brought in & patient connected. Per BIOMED report: expiration lever was in the "up" position.

The lever is able to be moved to the "up" position during moving the ventilator without the knowledge of the RT. The ventilator had already passed the initial internal self check.

Manufacturer response (as per reporter): Biomedical Technician contacted technical support at Covidien. Biomed Tech advised to check for leaks. Upon inspection of the circuit, it was noted the exhalation filter latch was in the "up" position.

See device images:
Ventilator - 840 Vent

Ventilator - Latch Closed

Ventilator - Latch Open


GENERAL & PLASTIC SURGERY

Device:
Type: Tray, Incision &Drainage
Manufacturer: Centurion Medical Products
Model #: ID1190
Lot #: 2009083190

Problem:
Saline or Betadine was leaking and caused rusting of the scissors. Tray was not used and another tray was utilized.

Device:
Type: Breast Biopsy Device
Manufacturer: Hologic, Inc.
Brand: Suros Atec Eviva
Model #: EVIVA 0913-20
Cat #: EVIVA 0913-20

Problem:
While doing a stereotactic breast biopsy, every time the radiologist fired the biopsy needle, the calcifications we were trying to biopsy were being pushed away.

Manufacturer response (as per reporter): the hospital discussed our concerns with Hologic during a teleconference. Hologic informed us that they have enhanced their QC in response to user experience feedback from multiple facilities.


Device:
Type: Trocar, Dissector System
Manufacturer: United States Surgical Corporation- Tyco Healthcare
Brand: Spacemaker Plus
Model #: 10000-33858
Other #: SMBTT0VL

Problem:
A hernia dissector was used in a laparoscope procedure where the device contained latex and was not properly labeled as containing latex. There seems to be a lack of a standard on when there are labels to warn about latex on this product (some are marked and some are not).

See device images:
Latex - Comparison of boxes where one is marked as containing latex and the other is not

Latex - Comparison of top of boxes where one is marked as containing latex and the other is not


Device:
Type: Fixation Device
Manufacturer: Covidien United States Surgical Corporation
Brand: Protack
Lot #: P9M0816
Cat #: 174006

Problem:
ProTack would not fire properly.

Comment from FDA: Please see Class II recall online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88661


Device 1:
Type: Power Supply
Manufacturer: MAQUET CARDIOVASCULAR LLC
Brand: Vasoview
Model #: VH-3010

Device 2:
Type: Endoscopic Vessel Harvesting System
Manufacturer: MAQUET CARDIOVASCULAR LLC
Brand: Vasoview Hemopro
Lot #: 25004131
Cat #: VH-3000

Device 3:
Type: Endoscopic Vessel Harvesting System
Manufacturer: MAQUET CARDIOVASCULAR LLC
Brand: Vasoview Hemopro
Lot #: 250037000
Cat #: VH-3000

Device 4:
Type: Endoscopic Vessel Harvesting System
Manufacturer: MAQUET CARDIOVASCULAR LLC
Brand: Vasoview Hemopro
Lot #: 13004189
Cat #: VH-3000

Problem:
When the Physician Assistant began the endoscopic saphenous vein harvest using a Harvest Kit, an excessive amount of smoke was noted coming from the Vasoview Hemopro Endoscopic Vessel Harvest device/insertion site. Upon removal, the harvest device appeared to be excessively hot and smoking. The device was replaced with Harvest Kit #2 (Vasoview Hemopro Endoscopic Vessel Harvest device set). The new set was tested outside of the patient's body prior to use and was also found to produce excessive heat. The Active Extension/return cord to the Vasoview Power supply was replaced and another different Harvest Kit (#3) was attached. Again the Vasoview Hemopro Endoscopic Vessel Harvest device became too hot and the endoscopic approach was abandoned and the saphenous vein was harvested using an open approach.
Endoscopic visualization of the leg after the device failures revealed a quarter-sized area of subcutaneous adipose tissue had been cauterized. There were no external indications of a burn. The patient's leg was dressed normally. When the dressing was removed 48 hours later, no external blistering of the skin was noted.


Device:
Type: Laser Fiber
Manufacturer: American Medical Systems, Inc.
Brand: Green Light Hps Bph Fiber Optic
Lot #: 10-2090-946Z
Cat #: 0010-2090

Problem:
During laser vaporization of the prostate, the tip of the laser fiber broke off in the patient's bladder. The surgeon retrieved the tip. Notes from the operative report: "Approximately 50,000 joules were used to laser the prostate tissue. Unfortunately, at the end of this procedure, the laser fiber broke. It was adequately removed; however, there appeared to be a malfunction on the laser procedure. We went through approximately 10 or 12 fibers, none of which were working properly. At this point, I chose to convert to the electrocautery and used a rollerball to adequately coagulate and remove additional tissue. At this point, the procedure was terminated. The patient was discharged to the recovery room in stable condition without intraoperative complications."


Device:
Type: Laparoscopic Tissue Retrieval System
Manufacturer: Anchor Products Co.
Lot #: Q06N
Cat #: TRS175SB

Problem:
During a laparoscopic splenectomy, one of the two metal prongs from the tissue retrieval system broke off inside the patient and was retrieved. Small lacerations were noted on the abdominal wall peritoneum that appears to be caused by the broken end of the prong. Each of the two metal prongs has a hole for a swivel pin. The one prong broke at sides of this hole.


Device:
Type: Trocar
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Endopath Xcel
Model #: H12LP
Lot #: F4R25J
Other #: 12 mm blunt tip trocar

Problem:
The Hassons that are in the 12mm blunt tip trocar (Endopath Xcel) ref H12LP are leaking. They were both from lot number F4R25J.


Device 1:
Type: Fixation Device
Manufacturer: Covidien United States Surgical Corporation
Brand: Protack
Lot #: P9L0831
Cat #: 174006

Device 2:
Type: Fixation Device
Manufacturer: Covidien United States Surgical Corporation
Brand: Protack
Lot #: P9M0312
Cat #: 174006

Problem:
During surgery, after the tacker was fired, the device locked up. The second ProTack was used with the same results. A third ProTack was used from different lot number and worked fine. No harm to patient.


RADIOLOGY

Device:
Type: Mri, 3t
Manufacturer: Siemens Medical Solutions
Brand: Verio
Model #: 10276755

Problem:
A ceiling light fixture located above the MRI caught fire. The MRI team members depressed the MRI quench and power buttons in the MRI suite. Hospital staff from various areas responded to the MRI suite with fire extinguishers. The city firemen were allowed into the MRI suite area to fight the fire and remove the smoke. Firefighters were told that the magnet may not be quenched. Firefighters entered the MRI suite with their ax after shedding other metal equipment. A firefighter's tool was pulled into the bore of the MRI when the firefighter was approximately 3 feet away from the foot end of the MRI. There were no patients in the MRI when the fire occurred. Even though the quench button had been depressed, it was initially believed that the MRI unit maintained some magnetic field. Subsequently the MRI was ramped down to deactivate the magnetic field. The fire sprinklers did not activate; the heat was above the level of the sprinkler heads. No smoke detector is located in the MRI scan room due to the concern for RF interference. Further investigation determined that the MRI quench feature was operating properly. An electrical review of the quench button with logs verified that it was working. It appears that the staff did not fully engage the quench system by pressing the button fully. The button location may have made this quench process difficult, but there is another button that could have been pressed. The Siemens MRI in this report is supposed to have an audible alarm once the quench is activated. An audible alarm was not heard during the quench process. Our Phillips and GE MRI's do not have any audible alarm when the magnet is quenched. For Philips and GE, staff would check the nitrogen and helium levels in equipment rooms to determine if the magnet is quenched.

MRI education is being revised and will be offered to all radiology staff and select Integrated Service staff (housekeepers, plant operations, security). Hospital is working with other metro hospitals to create a metro-wide MRI safety policy and work with local fire departments in cities that we operate MRI's. The ax was removed from the bore of the MRI. The MRI was thoroughly assessed and experts determined that the equipment can be refurbished and extensively cleaned, with replacement of the couch.

Manufacturer response (as per reporter): Siemens representatives were onsite after the fire and participated in the investigation of the cause of the fire, the testing of the quench button, provided documentation of training, and helped determine that the MRI can be refurbished.

Device:
Type: X-ray System, Cath/angio
Manufacturer: SIEMENS
Brand: Axiom Artis

Problem:
Patient had emergent cath with intervention. It was discovered that images of procedure were not transferred from the Siemens imaging equipment to the McKesson archives. Cath lab team members did not follow process put into place to ensure that images are transferred prior too deleting them from Siemens which has a finite amount of memory space. There is no way to retrieve the images. No harm to patient.


ORTHOPEDIC

Device:
Type: Spinal System Pedicle Access Needle
Manufacturer: Medtronic Sofamor Danek
Brand: Medtronic Nim Spine Pedicle Access Needle
Model #: REF # 9450020

Problem:
Patient with spinal stenosis from spondylolysis and spondylolisthesis had a posterior lumbar interbody fusion with pedicle screw fixation. The NIM (Medtronic) probe was inserted during the surgical procedure. When the probe was removed, portions of the plastic cover were sheared off. Surgeon was aware of this, and was unable to detect under fluoroscopy any fragments retained in the patient. The patient's wound was visually inspected, irrigated and closed. The surgery team was unable to determine if there was any patient injury or retained object; none was visualized or via x-ray. The patient had an uncomplicated post-op course and was discharged home on post-op day 5 with home health services, home physical therapy and home occupational therapy. Visual examination of the NIMS probe shows that approximately 1 inch of blue Rilsan coating is missing from the end of the probe. The edges have a sheared appearance.

Manufacturer response (as per reporter): Sales representative provided a Medtronic QA article citing biocompatibility evaluations on Rilsan insulation coating and literature references on nylon implants to support the biosafety of Rilsan if a small amount of Rilsan coating is retained in a patient's body due to chipping of the coating during surgery.


GENERAL HOSPITAL

Device 1:
Type: Emr System
Manufacturer: Cerner Corp.
Brand: Powerchart

Device 2:
Type: Monitor, Physiological, Data Base Server
Manufacturer: Philips Medical Systems
Brand: Intellivue Large Database Server

Problem:
We have a Cerner EMR system that is connected to a Philips patient monitoring system to chart vital signs (VS) semi-automatically. The system requires the nurse to request the VS be downloaded, verify the VS and have them post to the patients chart. Several times the staff reports that vital signs have been downloaded, viewed, approved and have subsequently disappeared from the system. Cerner apparently was aware of the problem and installed a "patch" to fix it. The frequency of the problem had significantly decreased but the problem continues to present. This is a complex problem and troubleshooting requires collaboration between in-house biomed, the hospital's corporate IT EMR team, and the Cerner troubleshooting team.

Device:
Type: Blood Collection Set
Manufacturer: Smiths Medical ASD, Inc.
Brand: Saf-t Wing
Lot #: 1628475
Other #: 21g x 3/4" winged needle with 12" of tubing. A case consists of 4 boxes of 50.

Problem:
When using this device to draw blood specimens, after the 3rd or 4th tube that is drawn, the inner needle does not sheath completely, allowing blood to flow out of the needle into the Saf-T Holder. If another tube is drawn, the outside of the tube is then contaminated with the patient's blood. The device does not leak when 3 or fewer tubes are drawn. This problem was reported to the Smiths Medical rep in December 2009. I reported it again in January 2010. I was contacted by Smiths Medical to assure us that they were aware of the problem. I asked the HIV clinic manager to save some of the leaking devices for me. I picked them up today from the clinic and took them to Safety Office.

Staff feels that the stop mechanism in the blood drawing system is failing after being exercised with multiple sample draws.

Manufacturer response (as per reporter): Manufacturer is aware of the problem reported earlier in 2009.

Device:
Type: Laser Fiber, Surgical, Reuseable
Manufacturer: Lumenis, Inc.
Brand: Slimline
Model #: 365 Micron Blue Jacket Reusable Fiber
Lot #: 89990509

Problem:
During the first half hour of an endoscopic laser stone extraction, the laser fiber failed, requiring replacement of the fiber in order to proceed with surgery. The initial attempt to remove the fiber revealed that an approximately 0.5 meter section of the fiber had separated from the proximal fiber and was still within the patient. The remainder of the fiber was endoscopically extracted. No injury to patient or staff occurred. This was the third laser fiber break in a month but the first inside the patient. Laser power levels in use were well under the power ratings for the reusable fibers. A review of the manufacturer's recommendations for processing these reusable fibers revealed that there are limits on how tightly they can be looped for packaging and storage. Packaging of these fibers at our facility was being performed with tighter loops than recommended which might be contributing to the failures.

Mechanical failure of the laser fiber interrupted the surgical procedure. This failure potentially could have resulted in misdirected laser energy injury to the patient or staff. Also a very short piece of fiber being left inside the patient might not have been noticed.

Manufacturer response (as per reporter): The manufacturer has indicated that conversion to a single use fiber should eliminate this occurrence.

Device:
Type: Port, Implantable
Manufacturer: Bard Access Systems
Brand: Bard
Model #: 1808000

Problem:
The patient had a left internal jugular infuse-a-port placed. Approximately five months later, the patient began having swelling in the neck. This was thought to be due to a leak in the port itself. The patient was taken to surgery and the port was removed. After speaking with the MD, he did state there had been recent difficulty with flushing the line. The patient then presented with neck swelling. The MD believes there is a crack in the catheter portion of the power port. The device has been retained in Risk Management.

Device:
Type: Therapeutic Mattress Control Unit
Manufacturer: Encompass Therapeutic System Support
Brand: Accumax Quantum Ta
Model #: CU 3
Other #: P/N 400305

Problem:
This is the Encompass CU 3 Therapeutic Support control unit that burned a hole in the top of the device. I am not sure if it was being used at the time the failure occurred. We pulled all the CU 3s out of service and since then there was another CU 3 that was out of service in our warehouse that also started to melt the top plastic case in the same location as the other unit that previously failed.

Manufacturer response (as per reporter): They are planning to investigate the problem


Device:
Type: Hospital Bed
Manufacturer: Stryker Medical
Brand: Stryker 2040 Zoom Bed

Problem:
Unoccupied bed sent to bioengineering for not holding a charge.

Manufacturer response (as per reporter): The company is actively investigating this and the other 3 complaints we have reported as well as doing an internal investigation related to the specific plug used on their stretchers and beds that has been recalled by at least nine other manufacturers.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Catheter, Foley
Manufacturer: Bard Urological
Cat #: 1758S
Problem:
While removing patient's foley catheter, the tip became stuck at the tip of the patient's penis (the urethral opening). Lube was applied to help catheter come out. Still, the catheter had to be manipulated/tugged and patient experienced discomfort from this. The tip of the patient's penis was red and sensitive after removal was finally achieved. This catheter was the type that is inserted in the OR. There is a hard plastic ring that remains even after the balloon is fully deflated. The ring is at the tip of the catheter. Other catheters do not have this hard plastic ring at the tip of them (they are smooth and they do not get caught at the tip of the penis). The catheter was saved and is in the patient's room for inspection if desired.


Device:
Type: Lithotriptor Probe
Manufacturer: Olympus America Inc.
Brand: Olympus Ultrasonic Lithotriptor Probe
Model #: MAJ-985
Lot #: #9XR
Cat #: N1006700
Other #: size 3.7 mm

Problem:
During the use of a loaner Olympus Nephroscope and an Olympus Ultrasonic Lithotriptor with probe, metal flakes were noted within the patient's left kidney. There was an immediate halt of the procedure. There was an attempt to suction the metal flakes by the physician; but not all were able to be removed. The procedure was completed with alternate methods. All the equipment was evaluated after the case was completed. The machine was taken to Bio-Med with the hand piece. A picture was taken and given to the OR manager. The damaged probe was given to the OR manager. The loaner scope was returned to the manufacturer's representative.


Device:
Type: Hemodialysis System
Manufacturer: Edwards Lifesciences
Brand: Aquarius
Model #: GEF09800

Problem:
After starting the hemodialysis system, the degassing alarm sounded and troubleshooting efforts were unsuccessful in resolving the problem. The nurse recognized that blood was starting to clot in the tubing, and recirculated the blood back to the patient. The tubing was then replaced with new tubing. The alarm sounded again and the same problem of blood starting to clot reoccurred. At this point, the hemodialysis machine was changed to another machine of the same make and brand. Hemodialysis was performed without further problems. The manufacturer's service technician was called in to check the affected machine. The problem could not be duplicated by the technician.


EAR NOSE & THROAT

Device:
Type: Electrodes, Infant Hearing Screener
Manufacturer: Natus Medical Inc
Brand: Natus
Model #: Algo 2E
Lot #: N0521209-1
Cat #: 040517
Problem:
The nurses have complained many times about the difficulty of using the Natus hearing screener; especially, the Jelly Tab Sensors (electrodes) provided by Natus. The staff has tried to use the standard electrodes (3M Red Dot). They saw an immediate improvement in performance. The staff stated that the screen is completed in half the time. They had fewer difficulties with keeping the electrodes attached or obtaining a good signal. Natus sensors are designed for an infant's sensitive skin, but do not seem to perform adequately. Natus electrodes are not optimal for obtaining quality results quickly. The device lists the equipment as well as the Natus Jelly Tab Sensors.


OBSTETRICS & GYNECOLOGY

Device:
Type: Endoscopic, Laparoscope, Gynecologic, And Accessories
Manufacturer: KARL STORZ Endoscopy-America, Inc.
Brand: Storz Morcellator
Other #: 26713030(etched on device) CE 0123
Problem:
Unable to properly clean morcellator. After multiple washings, blood tinged fluid continues to flow out of drill. Able to insert fingernail along drum and more fluid flows out.


OPTHALAMIC

Device:
Type: Unit, Vitrectomy
Manufacturer: ALCON Research, LTD
Brand: Constellation Vision System
Problem:
Sudden shutdown of Constellation Machine. Constellation kept infusing after shutoff; however, when trying to restart, it cut off infusion and would not allow restart without a prime. Service rep came out to analyze and he stated this is another software bug that is supposed to be addressed in next version of software.

Manufacturer response (as per reporter): Unable to duplicate problem. No error in event log.


PHYSICAL MEDICINE

Device:
Type: Heat Therapy Pump
Manufacturer: Gaymar Industries
Model #: KMOD-107
Cat #: 64n07700
Problem:
Heat therapy pump (Kpad) was applied to patient's right knee. The patient also had a Lidoderm patch applied. The patient was noted to have a reddened area (first degree burn). The redness went away within 24 hours. No medication was applied. Additionally, clinical staff noticed the over temp light was lit. Unit was removed and sent to Biomed for evaluation. Initial inspection noted that unit's motor had seized and operating temperature was set to 107F. Normal operating temperature is between 103F to 109F. With tap to unit, motor restarted and unit operated without failure for three days. Unit failed after repeated check and operating temperature decreases when overtemp lamp is lit (i.e. the unit stops pumping). Our facility is working with the manufacturer to get the product returned for evaluation.

Comment from FDA: Medication patches, such as Lidoderm, warn against use of external heat sources with the patches. See Lidoderm product labeling, specifically the notation: “External Heat Sources: Placement of external heat sources, such as heating pads or electric blankets, over LIDODERM patches is not recommended as this has not been evaluated and may increase plasma lidocaine levels” online available at: http://www.endo.com/PDF/lidoderm_pack_insert.pdf.


Device:
Type: Pack, Hot Or Cold, Water Circulating
Manufacturer: Breg Inc.
Brand: Polar Care
Model #: pc 300
Lot #: 29957805
Other #: return # 5049557

Problem:
We are reporting two events in this one report. A nurse applied a polar care unit for cooling therapy to the patient's knee. The device was set up according to the manufacturer's instructions and plugged into an electrical outlet. However, less than 30 minutes later, the patient called the nurse to report that the unit was turning off and on independently. The RN checked the system and could not find any obvious defects. Engineering checked the electrical outlet and could find nothing wrong with it. The device was removed and a new one was obtained, which worked fine. The second event is nearly identical except that the polar care unit began to turn itself off and on almost immediately after the nurse plugged it into the electrical outlet. Staff are concerned that there may be a short in the electrical system inside the device that they cannot see. No patients or staff was harmed in either event. There are two different lot numbers for these products: 29957805 and 29960241. Both are the same model number (PC 300).

Device:
Type: Stretcher
Manufacturer: Stryker Medical
Brand: Stryker Sm304 Zoom Stretcher
Model #: 1025

Problem:
Stretcher fire in unoccupied room. Fire initiated at power cord/outlet. Extinguished per protocol. Fire within inches of oxygen supply.

Manufacturer response (as per reporter): The company is actively investigating this and the other 3 complaints we have reported as well as doing an internal investigation related to the specific plug used on their stretchers that has been recalled by at least nine other manufacturers.

See device images:
Charred plug on Zoom Stretcher manufactured by Stryker

Charred plug on Zoom Stretcher manufactured by Stryker


MICROBIOLOGY

Device:
Type: Cup, Urine Collection
Manufacturer: BD
Brand: Bd Vacutainer Urine Collection System Collection Cup
Model #: 364957, 364956, 364954, 364975

Problem:
We are reporting two incidents with this report. In both cases, patients were injured when using the Vacutainer urine collection system collection cup. In the first case, a male patient was given the specimen cup and instructed to provide a urine specimen. The RN told the patient to place the lid on the cup when he was done. The patient returned to the room and told his nurse that he was poked when he tried to provide the specimen. The patient had removed the label that covers the transfer device and tried to urinate into that part of the lid. In doing so, the cover that sheathes the needle was pushed back and he was stuck. In the second case, a female patient was given similar instructions. The patient told the nurse she was stuck on her finger when she tried to push down on the rubber covering that sheathes the needle (the patient had removed the label and urinated into the transfer well on the specimen lid. The manufacturer made a change to the label on this device's container. Previously, the label had a large red circle with a slash through it along with lettering that informed the patient not to remove the label. In December of 2009, the label was changed to show a finger poking into the well with a red "X" through it and three numbered photos for how staff are to use the device to obtain a specimen in a tube from the cup. Patients are misreading the label despite staff's verbal instructions on how to use the device.


HEMATOLOGY

Device:
Type: Hematology Analyzer
Manufacturer: Sysmex America, Inc
Brand: Sysmex Xe-2100
Other #: Reference #: 756292

Problem:
CBC (Complete Blood Count) printout from Sysmex XE-2100 Hematology Analyzer had patient demographics for one patient, but had a different patient's results. Sysmex was contacted. All pertaining documents have been copied and forwarded to Sysmex. Sysmex did not have an explanation and stated an investigation would be opened.


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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events Involving Surgical Laser Fibers

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Surgical laser fibers are optical fibers used to deliver laser energy to the desired surgical site from surgical lasers, typically Holmium YAG, ND YAG or certain diode lasers. They are classified by the FDA as accessories to the appropriate surgical laser(s) with which they are used, and cleared for specific intended clinical use(s) [1]. Although such lasers are versatile and may be used in a variety of surgical procedures, some of the most frequent uses, as reflected in these reports are:

1. Laser vaporization of the prostate surgery or laser assisted TURP procedures
2. Laser lithotripsy of kidney, bladder or biliary stones
3. Endovenous laser treatment (EVLT) for varicose veins

Surgical laser fibers are available from a number of manufacturers and are designed as either single-use, or reusable fibers. Reusable fibers require that a user properly clean the fiber after use, “cleave and strip” the distal (patient) end of the fiber, carefully inspect the end of the fiber using a magnifying scope, examine the appearance of the laser aiming beam as projected from the “reprocessed” fiber, and if satisfactory, sterilize the fiber for the next use. If reprocessing is not done properly, excess heat at the fiber tip can lead to thermal injuries or fires [2].

Surgical laser fibers are fragile and require careful handling and manipulation during use, in order to avoid damage to the fiber.

Over the past 2 years, MedSun has received 43 reports involving surgical laser fibers, both single use and reusable. The laser fibers associated with the reports were manufactured by 13 firms in total: American Medical Systems, Inc. (17), Lumenis, Inc. (12), Vascular Solutions, Inc.(1), Gyrus Medical, Inc.(1), Laser Peripherals, LLC (1), ForTec Medical, Inc.(2), Trimedyne, Inc.(1), Fibertech, USA, Inc.(1), Biolitec, Inc.(3), Diomed, Inc.(1), Laserscope, Inc.(1), Mackin Medical, Inc. (1) and PRI Medical Technologies, Inc. (1) (It should be noted that Boston Scientific is a distributor for a number of these fibers.) The reports were submitted by 29 hospitals between April 2008 and March 2010.

The overwhelming majority of reports involve breakage or fracture of the fiber itself. Depending on the location of the break, this can result in a laser burn to the patient or user, damage to associated instruments (such as the scope through which the fiber is placed), or the need to remove the fiber fragment(s) from the surgical area. Of course, breakage may also lead to delays of the procedure, ineffectiveness of the procedure or the need to change to another (non-laser) surgical technique.

Categories of reported device problems are shown below: (Note that a report may be assigned to more than one category, i.e. a break/fracture may also involve a burn.)

-Fiber break/fracture (not retained in patient): 33
-Defective, inoperable, ineffective: 9
-Injury to user: 5
-Damage to surgical instrument(s) as a result of fiber break/fracture: 4
-Fiber break/fracture (retained in patient): 2
-Injury to patient (not incl. retained fragments): 2

As shown above, there were 7 instances in which there was an injury to either the patient or user – a burn or other thermal injury. The injuries to users were generally minor burns to the hand after fracture of the laser fiber, and in one case an OR staff member received a minor burn in the abdominal area when a fractured fiber contacted that area.

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 34 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 27 reports involved male patients.

The following table lists the MedSun reports that are described in the device problem summary above. Note: event descriptions have been changed for clarity.

Adverse Event Table
Manufacturer, Brand NameDevice Identifiers (model, catalog number, lot) Event Description
American Medical Systems, Inc., InnovaQuartz AccuFlex M0068408020, 840802, TRF0619B While using the Holmium laser on patient, the 200 micron Accuflex fiber snapped and burned the surgeon's hand. The patient was not harmed. Local first aid to surgeon's 1st degree hand burns.
American Medical Systems, Inc.,GreenLight HPS none, 0010-2090, 10-2090-001D During procedure (Photovaporization of the prostate), laser fiber broke off in the patient. The piece was retrieved. Notes from the operative report: "A large stone was encountered in the left and this damaged the fiber, which was removed in toto. A second fiber was introduced and resection was completed. Patient to recovery in good condition."
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-949A During laser TURP with GreenLight laser fiber, the tip broke off in the patient. The tip was retrieved by the surgeon. No patient impact; the patient was discharged in stable condition.
American Medical Systems, Inc., InnovaQuartz AccuFlex Two (2) Devices - all: 840802, M0068408020, TRF1339B Laser fiber broke intraoperatively. Two fibers malfunctioned. The first one broke - the broken piece was retrieved. The second fiber snapped so that the beam was coming from the underside of fiber. Burned a hole in the ureteroscope.
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-946Z During laser vaporization of the prostate, the tip of the laser fiber broke off in the patient's bladder. The surgeon retrieved the tip. Notes from the operative report: "Approximately 50,000 joules were used to laser the prostate tissue. Unfortunately, at the end of this procedure, the laser fiber broke. It was adequately removed; however, there appeared to be a malfunction on the laser procedure. We went through approximately 10 or 12 fibers, none of which were working properly. At this point, I chose to convert to the electrocautery and used a rollerball to adequately coagulate and remove additional tissue. At this point, the procedure was terminated. The patient was discharged to the recovery room in stable condition without intraoperative complications."
Lumenis, Inc., Slimline 365 micron, none, 89990509 During the first half hour of an endoscopic laser stone extraction, the laser fiber failed, requiring replacement of the fiber in order to proceed with surgery. The initial attempt to remove the fiber revealed that an approximately 0.5 meter section of the fiber had separated from the proximal fiber and was still within the patient. The remainder of the fiber was endoscopically extracted. No injury to patient or staff occurred. This was the third laser fiber break in a month but the first inside the patient. Laser power levels in use were well under the power ratings for the reusable fibers. A review of the manufacturer's reccommendations for processing these reusable fibers revealed that there are limits on how tightly they can be looped for packaging and storage. Packaging of these fibers at our facility was being performed with tighter loops than recommended which might be contributing to the failures. Mechanical failure of the laser fiber interrupted the surgical procedure. This failure potentially could have resulted in misdirected laser energy injury to the patient or staff. Also a very short piece of fiber being left inside the patient might not have been noticed. Manufacturer response (as per reporter) for Surgical Laser Resuable Fiber, SlimLine The manufacturer has indicated that conversion to a single use fiber should eliminate this occurrence.
American Medical Systems, Inc., InnovaQuartz none, none, TRF0387A A Holmium laser lithotripsy probe was inserted and put in contact with the stone. It did fragment the stone, however the pieces migrated away from the scope. After multiple attempts, at different angles, they could not be reached. Switched over to a flexible scope leaving a second guidewire in place. The stones could then be visualized, although there was a fairly significant difficult angle with the scope. It was then possible to get the lithotripsy probe in contact with the stone and treat the significantly large piece which was left. After multiple attempts with this, the laser probe actually broke and the flexible cystoscope just distal to it. The laser burned the lens, so at this point the cystoscope was no longer useful. The ureter looked normal with no sign of any injury or perforation. The patient will need to return for lithotripsy.
American Medical Systems, Inc., GreenLight none, 0010-2090, 10-2090-941C MD stated that the GreenLight laser fiber "exploded" inside the patient. MD retrieved fiber pieces and irrigated patients urethra/bladder with saline. No injury noted. Fiber pieces were given to laser rep.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840802, M8408020, none The doctor was using the holmium laser in outpatient surgery with a 200 micron laser fiber. The laser fiber snapped and gave the surgeon a small burn - he had a small white area on his finger from the burn. The laser fiber was removed from the patient. No apparent harm to the patient was noted.
Laser Peripherals LLC HB-200, HB-200, LP-548 The Nurse stated that when being used on the patient, the laser fiber broke. It appears that the fiber broke off about 1/3 of the length towards the proximal end. There were no pieces or fragments identified that could have been retained. Another fiber was opened and the procedure was completed. No harm.
Lumenis, Inc., SlimLine EZ 550 M0068408941 ,none, 85850209 The doctor was unable to pass the fiber through the GI scope and when it came out of the scope, the light was not visible. When the staff removed the fiber, it was noted the tip fractured about 1/2 above the end.
Vascular Solutions, Inc., Vari-Lase 18918, REF#7112, 546508 Patient admitted to Outpatient Surgery Center for right anterior lateral greater saphenous vein endovenous laser ablation with multiple stab phlebectomies. Vari-Lase laser was used. A Vari-Lase standard kit, 4fr, 45 cm sheath was opened per physician's request. Sheath was placed. Laser fiber was advanced through the sheath. Click/lock method was used to hold the laser fiber in the sheath, although I (the surgeon) felt that the lock mechanism was a bit loose. I started the laser and pulled back the sheath and fiber together, burning 100 Joules per centimeter, total length of 16 cm. When I pulled the laser fiber out through the skin incision, the laser fiber was flush with the sheath rather than protruding 2 cm as is standard. The tip of the sheath was singed and, while I do not think that any part of the sheath was burned into the anterior lateral GSV, I cannot be completely sure that there are no residual burned pieces of plastic sheath within the patient. I looked to the click/lock mechanism which holds the laser fiber stationary within the sheath and the mechanism had come undone and the laser fiber was moving freely within the sheath. I had the sheath and laser fiber saved for further evaluation. RN circulator in the room called the vascular lab at the request of Dr. for nurse to bring another ultrasound machine to the room. Ultrasound was performed and no pieces of plastic were noted by either nurse or Dr. The patient remained stable during the procedure. After the procedure the patient's husband was brought to the conference room by Dr. and RN was also present for the conversation while Dr. explained the incident to the husband. It was also explained to the patient. Dr. told the patient and husband potential complications to be aware of.
Lumenis, Inc., SlimLine F7D4411145, M006840840, 80770908 Surgeons requested 200 micron laser fiber. SlimLine 200 Fiber Delivery Device was opened. Surgeon began using the fiber but complained that it is not working. It made a clicking sound which is different than the usual sound when pedal pressed. Surgeons requested another fiber; new fiber worked.
American Medical Systems, Inc., InnovaQuartz AccuFlex none, 840802, TRF1837P The surgeon was operating the holmium laser. Smoke was found coming from the laser fiber where the blue laser fiber enters the dark blue sheath.
Lumenis, Inc., SlimLine EZ 840-893, M0068408930, 86500209 For lithotripsy precedure, the laser fiber device was attached to the laser generator, and fed through ureteroscope. The end of the fiber device was placed near the stone, and activated. During the procedure, it was seen on the monitor that the fiber device was not working, i.e. there was no laser pulse being applied to the stone. The device was removed for inspection, and it was noted that a 3 cm piece of the end of the fiber device had broken off and remained in the patient. The broken piece was retrieved with a grasper. There was no known injury to the patient.
American Medical Systems, Inc.,GreenLight HPS 0010-2090, none, 10-2090-927L GreenLight HPS laser fiber probe fractured as it was being using during GreenLight laser TURP. All pieces were retrieved per Dr. Fiber will be returned to the company. Procedure was started with the laser, then converted by the surgeon to ESU then back to laser for completion of case. Fiber broke at 120 watts. End of tip extracted via Cystoscopy per Dr. Gland volume was 60 ml, 12.5 minutes expended, energy expended 62418 joules.
Lumenis, Inc., DuoTome SideLite 840-846, M0068408460, 85750209 Laser fiber tip came apart in patient's bladder with the first pulse - tip was removed completely.
ForTec Medical, Inc., ForTec Fibers DHBFSF230-DO, none, none Laser fiber wire defective. Opened new one and it worked fine.
American Medical Systems, Inc. none An adolescent patient was admitted to the hospital with three-month history of persistent pneumonia. CT scan showed calcified mass obstructing the right middle lobe takeoff intraluminally. A surgical procedure was scheduled for direct laryngoscopy, bronchoscopy and biopsy of mass with KTP laser. Patient was initially intubated and a flexible adult fiber optic bronchoscope was placed through ETT. Biopsies were obtained using a flexible biopsy forceps through the bronchoscope. The KTP laser was used to control bleeding. The patient had initially been ventilated with 21% FiO2 at the start of the case but with continued desaturations secondary to airway leak around the bronchoscope the FiO2 was increased to 100%. The surgeon was unable to remove the mass so the flexible bronchoscope was removed. A rigid bronchoscope was then placed and attempts to remove the mass were unsuccessful. Rigid bronchoscope was removed and patient was reintubated. Several more specimens were obtained using the flexible bronchoscope through the ETT. Bleeding was stopped using the KTP laser. Attempts were also made to ablate the mass with the KTP. A general surgeon was called to discuss the possibility of a transthoracic approach to remove the mass. The primary surgeon used the KTP to demonstrate to the general surgeon the hardness of the mass. As the laser was engaged the light of the bronchoscope went off. The laser was put on standby and the bronchoscope removed. Patient was extubated, oxygen turned off, anesthesia circuit disconnected and changed, patient masked and then reintubated. A small amount of smoke was noted in the ETT that was removed. Upon examination of the bronchoscope, it appeared as though one side of the scope had been melted. A flexible bronchoscope was passed through the ETT to examine the airway. This examination revealed evidence of melted plastic verses vaporized plastic from the end of the flexible bronchoscope. The patient was transferred from the operating room to the Pediatric Intensive Care Unit. The patient remained intubated until 2 days after the procedure, when she was successfully extubated. The patient remains hospitalized and is scheduled to return to the operating room for removal of the mass.
Gyrus Medical, Inc. Three (3) Devices - Quantity 2: 1000 micron fiber, lot ID2707s and D2808s, and Quantity 1: 600 micron fiber, lot C2808s Procedure - cystolithopaxy with Holmium laser. 1000 micron fiber(ACMI lot# D2707s exp 2010-07) was opened and laser beam had a crisp circle- when placed through the 23FR continuous flow cystoscope, the fiber appeared to be cracked. This fiber was replaced with another 1000 (ACMI lot# D2908s exp 2011-07) and this appeared to have a slight crack - it functioned without any problems. After a short time, the tip broke off. The beam looked fine and the MD continued to use this fiber. MD requested to use a 600- micron fiber (ACMI lot#C2808s exp 2011-07). This fiber appeared to shed its outer coating of the fiber itself- not the insulation. This fiber was replaced with another 600 fiber and that fiber was used for the remainder of the case.The fiber was passed through a COOK Check-Flo adaptor that has an ID of <= 9.0 FR which accomodates the 1000 micron fiber.
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-851R-3056 Patient undergoing photovaporization of prostate with GreenLight laser. During the procedure the laser fiber tip broke off while in the patient. The surgeon was able to retrieve the tip without injury to the patient. The representative from the contracted laser provider took the broken fiber tip with him to include with his report to his company.
Trimedyne, Inc. 20017m, 17316k Patient had left ureteral stone. Surgeon was preparing to use the Holmium laser to crush the stone when he noticed something strange in the ureter. He removed the laser fiber and looked for any damage. Damage was not immediately noted. Upon reinsertion of the ureteroscope, the surgeon identified a foreign object inside the ureter and used grasping forceps to remove the object. The object appeared to be part of the outer covering sheath. The laser fiber was immediately taken out of service.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840804, M0068408040, TRF1358E Boston Scientific Accuflex Holmium Laser Fiber broke distal to insertion in patient during the procedure. Another fiber was used to complete the procedure without incident. No harm to the patient.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460F, 62010807 While doing laser ablation of prostate with holmium laser, just after activation, the laser fiber burned through approximately one inch from hub, burning the surgeon's hand and finger.
Fibertech USA, Inc. Bare Fiber, FT IR200/220ST-3/SM-F, 703044 During laser lithotripsy, laser fiber broke into two pieces outside the patient. All fiber parts able to be removed by physician. Used new fiber to complete the case. No patient harm.
Lumenis, Inc., SlimLine 365 none Patient undergoing extraction of an ureteral stone with holmium laser. During the procedure the laser fiber made an audible "pop" noise and flashed. All staff and the patient were wearing eye protection. There was no evidence of laser contact to skin (of patient or staff). The laser unit and fiber were removed from service and inspected by a biomedical engineer. The laser unit was tested with a test fiber and found to be functioning properly. The blast shield was replaced because it was "damaged." (The blast shield acts as a "fuse" and protects the laser's internal components in the event of a fiber failure.) The laser was placed back in service. The engineer did not inspect the fiber, but it was retained in the event the manufacturer requests to inspect it. The laser fiber is a reusable item. We do keep track of how many times they are used/sterilized. They can be used up to ten times, but usually do not achieve that number. They are inspected and trimmed with a tool after each use. The fibers can be used up to 10 times. We keep track of the times the fiber has been used/sterilized by marking the container the fiber is sterilized in. We have a cutting/triming tool for the fibers according to size. The reuseable fibers are discarded for the following reasons: 1. The fiber is trimmed to the point that it's too short to reach from the laser to the sterile field. 2. The fiber has been used 10 times. 3. After each trim, the fiber is checked with an inspection scope to check for damaged fibers. If there are damaged fibers that can't be trimed, the fiber will be discarded. 4. There is a blast shield on the laser. If this needs to be replaced during a case, the fiber that is being used is dicarded because you can't be sure that the fiber has caused this. Fiber failure can cause injury to staff/patient, but in this case there was no adverse outcome.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460, 70930208 The laser fiber tip degraded during laser prostate procedure. Power setting was 2 joules and 50 hertz for a total of 100 watts. Fiber was removed from use and a new one opened. Manufacturer rep was present during procedure and witnessed occurence. No harm to patient. Patient was discharged the following day with no complications from incident.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460, 60590707 Laser fiber was placed at the 5 O'Clock and 7 O'clock position, turned on, resecting the tissue and opening the neck of the bladder when the tips broke off. Tips removed with grasping forceps.
American Medical Systems, Inc., GreenLight PV 10-2079-8182, Ref 10-2079, none Surgeon stated the tip had peeled off the Laser Fiber (it was not in the patient). The key on the Laser was inadvertently hit while opening the 2nd fiber and turned to the off position. The machine rebooted 12/14 self tests then displayed problem 122. The machine was turned off and rebooted successfully. Clinical Engineering was called and the procedure was completed with the second fiber without incident.
Lumenis, Inc., SlimLine 365 none, none, 52060207 Behind Dr. as he was using a Holmin Laser, Laser fiber screwed to unit (checked by Dr, RN) holding it for Dr. It broke and hit employee. Burn on left side of abdomen.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840804, M0068408040, TRF 036F The tip of the Holmium laser fiber (Boston Scientific, Accuflex) broke off as the surgeon was lasering the stone. The tip was retrieved in the stone.
Biolitec, Inc., SideFiber none, SF-980-DL, E08-0261-B Patient undergoing cystoscopy with laser photo vaporization of the prostate. During procedure laser tip broke inside the bladder. The tip was retrieved intact with the use of a zero-tip basket. The operation then continued with a new laser fiber. When the basket was returned to the tech it was noted that the basket was intact but could not be extended.
American Medical Systems, Inc., GreenLight none, none, 10/2079 714D First: GreenLight Laser Probe was plugged in - it said it was expired, although the outside of the box stated it was OK. Second: Green Light Laser Probe broke during use.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840803, M0068408030, TRF2957F Boston Scientific Holmium Laser Fiber 273 Micron, ACCUFLEX snapped in half during use. Fiber broke approximately 6 inches from machine (not in contact with patient). The laser was turned off and removed from the field. Another fiber used without incident. No harm to patient. The Holmium laser was checked by clinical tech, and no problems were noted with it.
Mackin Medical Inc. none, HOL1040F, M04845 After using the laser to break up ureteral stone surgeon noted a piece of 'blue' amongst yellow stone pieces.
Diomed, Inc., Optiguide none, DCYL 210, 4102001 During the spyglass ERCP procedure of the common bile duct with the PDT probe, the tip of the fiber broke off immediately proximal to the bifurcation. Approximately 1 cm of the glass tip remains in the common bile duct.
Laserscope, Inc. 10-2079-722E, 10-2079B, none Pt was undergoing a Prostate Vaporization Procedure (PVP) and the laser fiber appeared to be frayed when looking at it through a video camera. The fiber was removed by the physician and examined. The fiber still appeared to be frayed and was replaced. The defective fiber was taken out of the room and sent to the manufacturing company for further review of the product. The procedure continued without further incident.
ForTec Medical, Inc., ForTec Fibers DHBFSF365-BT, CRM083003, c08-0177-b While the physician was firing the laser for the procedure, the laser fiber broke approximately 3 feet distal to the insertion site of the laser. Laser placed in stand-by. A new laser was used without further incident.
Lumenis, Inc., DuoTome SideLite 550 840803, none, TRF2645E During a procedure, the device broke in the flexible ureterscope and segment was removed uneventfully.
Biolitec, Inc., SideFiber none, SF-980-DL, A08-0054-A During Laser treatment with Biolitec machine (by company representative)-He stated that the tip of the SideFiber Assembly, broke off -just a tiny piece. The surgeon stated that this sometimes happens and it is either sucked out or the patient will urinate it out. Exam was done with cystoscope after Laser procedure.
Lumenis, Inc., DuoTome SideLite 550 840-806, none, 67541207 A side laser fiber was placed to perform an ablation of the prostate. The ablation of the median bar of the prostate began (at 80 watts) when the laser failed, with subsequent breakage of the fiber, burning the physician's right palm. The patient was not injured.
Biolitec, Inc., SideFiber none, SF-980-DL, E08-0261-B Patient undergoing cystoscopy with laser photo vaporization of the prostate. During the procedure the laser tip broke off. It was retrieved with a stone retrieval basket. During the retrieval the basket malfunctioned and broke inside the sheath.
PRI Medical Technologies, Inc., Sure-Flex none Diode Laser Fiber was being used by the surgeon during a TURP. The 2 fibers broke inside the patient bladder. The surgeon was able to retrieve the fragments. No patient harm or delay in surgery.

Additional Information:

[1] The FDA Public 510(k) database may be searched for an overview of these devices by typing “laser fiber” under Device Name at:
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm

[2] “Patient Safety Advisory”, Produced by ECRI Institute & ISMP under contract to the Patient Safety Authority, Vol. 4, No. 1—March 2007, Page 5

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2007/mar4(1)/Documents/mar;4(1).pdf

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Updated May 1, 2010

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