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U.S. Department of Health and Human Services

MedSun: Newsletter #61, June 2011

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Newsletter #61, June 2011

Articles

Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall

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FDA MedWatch Safety Alert

Healthcare professionals were notified that there may be ratio pump wear, silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments (ion selective electrolyte flow cell) which may cause incorrect electrolyte results. This may cause serious adverse health consequences or death.

Additional Information:

FDA MedWatch Safety Alert. Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall. May 23, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256424.htm

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Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall

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FDA MedWatch Safety Alert

Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process.

Additional Information:

FDA MedWatch Safety Alert. Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall. May 10, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm254929.htm

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FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

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FDA Medical Device Safety

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are alerting health care providers that Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor.

Additional Information:

FDA Medical Device Safety. FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy. May 5, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm253237.htm

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Boston Scientific Devices Stolen - Risk of Infection

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FDA MedWatch Safety Alert

Boston Scientific Corporation is alerting the public about a stolen shipment of Endoscopy and Urology/Women's Health medical devices. These devices were stolen while en route to Boston Scientifics' sterilization facility sometime between April 8, 2011 and April 11, 2011. The labels on these devices state that they are "Sterile"; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.

Additional Information:

FDA MedWatch Safety Alert. Boston Scientific Devices Stolen – Risk of Infection. May 4, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm253937.htm

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Standardizing Emergency Medical Equipment

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Healthcare Purchasing News

Adverse events can be used to initiate process improvements. Interdisciplinary teams focused on quality and efficiency for the organization are instrumental in identifying holes. Working together for the same goal and mission is critical for enhancing quality care for the entire organization.

Additional Information:

Healthcare Purchasing News. Standardizing Emergency Medical Equipment. April 2010.
http://www.hpnonline.com/inside/2010-04/1004-PnP.html

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HeartNet

Featured HeartNet Reports 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 HeartNet. The following four events reported by MedSun HeartNet facilities contributed to two manufacturer actions:

The first reported event is associated with a Class II recall.

1. Featured MedSun HeartNet Report
Type of device: Pacemaker, Implantable
Device brand name: Adapta DR
Device manufacturer's name: Medtronic, Inc.
Date of this report: 07/02/2010

Describe the event or problem: Pacemaker checked via trans-telephonic monitoring and found to be demonstrating elective replacement behavior. The last clinic visit from three months ago had battery with estimated longevity of 7.5 years. The clinic visit today confirmed elective replacement behavior. The company was contacted for troubleshooting. Technical support indicated this is known issue that is remedied by a "special lab programmer". The condition is in the hardware for measurements. The device locks up and returns a battery voltage of zero and measurements are affected, after 12 hours, the device goes to ERI. The software fix will only unlock the hardware issue, however there is no indication thus far whether the issue will resurface. They have unlocked 12 devices so far and of those none have had a re-occurrence. If patient develops pacemaker syndrome, Medtronic recommends device change out. The programmer is being shipped to the local representative within the month. The patient was evaluated and found to be asymptomatic and verbalized understanding of symptoms that require immediate attention. The patient was discharged to home.
=======Health Professional's Impression =======
No adverse event as yet.

Related Recall: Please see the following Class 2 recall for the affected Implantable Pulse Generators manufactured by Medtronic. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99504

~~~
The following three events reported by MedSun HeartNet facilities are associated with a Class III recall.

2. Featured MedSun HeartNet Report
Type of device: compressor, external, cardiac
Device brand name: AutoPulse
Device manufacturer's name: Zoll Medical Corporation
Date of this report: 12/31/2010

Describe the event or problem: The AutoPulse was initiated for chest compressions during a resuscitation attempt. A freshly charged battery had been placed in the device 8 hours earlier. Another battery had been placed in the charger at that time. During the resuscitation, the device functioned for 2-3 minutes. Manual compressions were initiated. The first battery was then replaced with one that had been charged. After replacing the battery, the device functioned for only 3-5 minutes. Manual compressions were initiated and used for the duration of the resuscitation. After the second battery was placed, the device prompted the operator to start-restart-start continuously. Both batteries indicated a low battery warning on the AutoPulse while in use even though they had been charged. When the operator was unable to get the device to work they attempted to re-boot it. They were unable to turn the device back on from the "off state".

3. Featured MedSun HeartNet Report
Type of device: compressor, cardiac external
Device brand name: AutoPulse
Device manufacturer's name: Zoll Medical Corporation
Date of this report: 12/31/2010

Describe the event or problem: The AutoPulse device was initiated for chest compressions during resuscitation. The AutoPulse device functioned for approximately 5 minutes before it quit. Manual compressions were then initiated. The battery was replaced and the AutoPulse used again but the device only operated for 2-3 minutes. Manual compressions were resumed and used for the duration of resuscitation.

4. Featured MedSun HeartNet Report
Type of device: compressor, external, cardiac, powered
Device brand name: Autopulse Non-invasive Cardiac support pump
Device manufacturer's name: Zoll
Date of this report: 10/19/2010

Describe the event or problem: A middle-aged patient was coding in the cardiac cath lab. Attempted to use the Zoll Autopulse. Device did not work. All batteries were drained of power. All batteries were used and each only provided approximately five compressions and then failed. According to the Zoll rep, we have been changing out the batteries every day and draining/charging as instructed. Patient required mannual compressions for over an hour.
=======Health Professional's Impression =======
Current battery conditioner/charger is not putting the proper load test on the batteries to stimulate real life usage.

Related Recall: Please see the following Class III recall for the affected Auto Pulse Resuscitation System manufactured by Zoll. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98342

Additional Information:

1. Featured MedSun HeartNet Report. July 2, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%5DS9%25%5FL%20%0A&CFID=57608596&CFTOKEN=8c150327834c96ad-DBDA630

Class II Recall Medtronic Implantable Pulse Generators. April 29, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=99504

2. Featured MedSun HeartNet Report. December 31, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5F%3E%26%2FT%20%0A

3. Featured MedSun HeartNet Report. December 31, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5F%3E%26%2FH%20%0A

4. Featured MedSun HeartNet Report. October 19, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5D%5B%3E%26%3F%3C%20%0A

Class III recall Zoll AutoPulse Resuscitation System. April 7, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=98342

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HomeNet

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity

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FDA Home Use Medical Device Website

If you use a medical device that requires electricity to deliver care, this booklet provides you with a means to organize your medical device information. In addition, this booklet provides recommendations about actions you should take with your medical device during a power outage or other emergency situation. Print this booklet and have it handy for quick access and reference. Power outages are not predictable, and when they happen, you want to know where this booklet is immediately.

Additional Information:

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity.

http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/UCM252812.pdf

FDA Home Use Medical Device Website. Additional Resources Web Page.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/ucm204907.htm

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KidNet

Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines

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Recall - Firm Press Release

These devices are used by emergency medical services, hospitals, and other health care providers to measure exhaled CO2 during ventilation of infants and neonates. According to Oridion, the manufacturer of the devices, dislodged plastic strands may be found within the airway adapter which may then become inhaled by the patient.

Additional Information:

Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines. Recall - Firm Press Release. May 20, 2011.
http://www.fda.gov/Safety/Recalls/ucm256261.htm

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FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

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FDA News Release

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Menactra was originally approved in 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years.

Additional Information:

FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers. FDA News Release. April 22, 2011.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm252392.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period March 1 through March 31, 2011. 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.

ANESTHESIOLOGY

Device:
Type: Emg Endotracheal Tube
Manufacturer: Medtronic Xomed Inc
Brand: Nim Contact
Lot #: 71258000
Cat #: 8229506

Problem:
NIM machine was reading too much feedback for the stim one cord. We could not get feedback fixed. Switched to different NIM Endotracheal tube and feedback went away. The blue wire on the NIM Endotracheal tube didn't give feedback to the NIM Machine. They had to remove the tube and re-trach the patient with a new tube. The new one worked fine.

Device:
Type: Endotracheal Tube
Manufacturer: Covidien Nellcor Mallinckrodt
Brand: Reinforced Tracheal Tube
Model#: Cuffed
Lot #: 2001-03 4934
Cat #: 86553

Problem:
Intubated ICU patient, s/p [status post] craniotomy, was brought to MRI. Significant artifact was noted on MRI exam. It was subsequently noted that the ETT contained a metal reinforcement coil which interfered with the MRI. The product packaging and device do not indicate that the tracheal tube contains metal and is not safe for MRI scanning.

Device:
Type: Laryngeal Mask
Manufacturer: Anesthesia Equipment Supply, Inc
Brand: Aes Ultra Flex Cpv
Lot #: DG12117108
Cat #: 1037225

Problem:
LMA [Laryngeal Mask Airway] was tested prior to use by Anesthesiologist. Cuff on AES Ultra Flex CPV LMA (size 2.5, Lot # DG12117108) would not hold air once inflated. A total of 7 LMAs were tested & failed prior to finding one that worked. All were from same lot as listed above. As a result, remaining LMAs with this lot # were pulled from stock. We have been using these LMAs for approximately 2 years. We have not seen this issue previously.

Device:
Type: One-way Valve
Manufacturer: CareFusion 211
Brand: Airlife
Model#: 001800
Lot #: Y10S0086
Cat #: 001800

Problem:
During a pulmonary function test, albuterol was being administered through a one-way valve. During the inhalation, the soft movable piece of the valve separated from the device and was inhaled by the patient. Patient complained of initial discomfort but an attempt to recover the valve material through bronchoscopy was unsuccessful. Patient regained a feeling of normalcy, possibly having coughed up and swallowed the material.
======================
Manufacturer response for One-way valve, AirLife
======================
None as yet.

See device image:

 Image of the three components that make up the one-way valve.  One of the three components is the soft movable piece of the valve that separated from the device. <br>


Device:
Type: Oxygen Flowmeter
Manufacturer: Precision Medical Inc.
Brand: Oxygen Flowmeter
Model#: 2MFA1001
Other #: date code 5-95

Problem:
Nurse noticed something was not right with the flow meter and asked the charge nurse to check the flow meter. The patient was on an oxygen face mask connected to the flow meter involved in the incident. As the charge nurse entered the room she noticed that it smelled like something was burning. She observed that the flow tube was black. She had Respiratory Therapy paged to come to the room. She then began to turn down the flow meter, as she was adjusting the flow meter, it exploded and flames began to shoot out of the wall. A code red was initiated via the phone. The patient was immediately evacuated from the room and the door to the room was closed. The nursing supervisor turned off the oxygen to half of the unit. Security extinguished the burning pieces. There was no patient harm, employee injury or damage to the facility. Flowmeter had been in use for almost 4.5 days before this reported event occurred.
======================
Manufacturer response for Oxygen Flowmeter, Oxygen Flowmeter
======================
I spoke with Precision Medical representative. He took down my information and a summary of what occurred. He made a reference that there was a recall on this device in the late 1990's. He was going to research the previous recall. He mentioned that this was the first incident with this device that he was aware of in his 10 years with the company.

Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: GE
Brand: Engstrom Carestation
Model#: 1505-9000-000
Cat #: 1505-9000-000

Problem:
Unit shut down during transport of a patient. During biomed testing, the unit was turned on with the power cord plugged in. Ventilator was in stand-by mode. The ventilator was then unplugged from AC power. The LED for power turned off but the unit did not show that it was running on battery power ("On battery" dialog box and green battery symbol on graphic display did not present). Furthermore, the device did not produce the appropriate audible tone signifying disconnection from AC power. After about 2 minutes the ventilator shut down and the alarm did not sound for another 10 seconds.


CARDIOVASCULAR

Device:
Type: Physiological Monitor, Mri, Ecg Module
Manufacturer: MedRad, Inc.
Brand: Veris
Model#: 8600
Cat #: 3010459

Problem:
Thursday evening about 9:00 pm, the device was disconnected from its battery charger and placed at the foot end of the table of the Siemens Espree MRI scanner in preparation for the arrival of an ICU patient. That patient was kept in the hallway outside the room while their IV lines were being switched over to two MR compatible pumps, one of which encountered an unexpected air-in-line condition causing a delay. During that delay, the ECG module started to smolder and quick-thinking staff removed it from the exam room and called a Code Red. There was no harm to the patient or staff. The principle concern, however, is that the device has a short lead set so that when it is connected to the electrodes on a patient's chest, it is then laid on the chest and connected via a fiberoptic cable to the actual display monitor. A tech grabbed the smoldering device by the lead set and took it down a different hallway and placed it on another MR table that is kept there. A little later, he moved it to the floor. The smoke from the device did not set off the smoke detectors. (I found a reference to the company Nexergy on the charger.) The event was clearly the result of some kind of battery failure but we don't know the exact nature.
======================
Manufacturer response, according to reporter, for Physiological Monitor, MRI, Interface, Veris:
======================
They checked their records and tell us this has not happened anywhere or at anytime before.

See device images:

 Image of ECG module with smoldered area in the middle.  Image also shows lead set to the left of the smoldered ECG module.

 Image of MedRad label.  ECG Patient Module for use with Veris.  Manufactured by Nexergy by Egston.  Medical Charger information provided on label.  Output: 500mA at 7.4V.  Warning: Do not take into magnet room.  Contains Ferromagnetic Material.

Device:
Type: Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer: Abbott Vascular
Brand: Viatrac 14 Plus Peripheral Dilation Catheter
Lot #: 0051151
Cat #: 1008193-20

Problem:
During the procedure the surgeon took the post dilated balloon and dilated it up to 12 atmospheres and the balloon burst, leaving fragments of the balloon on the wire. The surgeon was unable to get the fragments to come into the shuttle sheath. After several attempts the surgeon was able to get the shaft of the balloon out. The surgeon then took out the shuttle sheath and advanced an introducer sheath and was then able to snare all of the remaining balloon fragments and the embolic protection system. The surgeon successfully removed the balloon fragments without complications to the patient.

Device:
Type: Catheter, Flow Directed
Manufacturer: Edwards Lifesciences
Brand: Swan-Ganz, Vip
Model#: 831HF75
Cat #: 831HF75

Problem:
I spoke with the nurse in the ICU who had the Swan-Ganz catheter. She stated, when the patient first arrived and was hooked up to the physiological monitors, the temperature would register normal thermal 98 degrees. After awhile it would slowly creep up until it registered 104 degrees. She said that they took the tympanic temperature, temple, and orally and they were normal thermal. She even checked the patient to make sure they did not feel warm. She said they changed the cables, module and used a different monitor. None of these changes made a difference.
======================
Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP:
======================
Sending box in to return and sending a replacement. Will also send report after examination of product.


Device:
Type: Clamp, Vascular
Manufacturer: St. Jude Medical (Radi)
Brand: Femostop Gold Sheath
Cat #: 11165

Problem:
Two RNs from cath lab at bedside to discontinue femoral sheath. Femostop applied per protocol and sheath was removed without incident. After approximately ten (10) minutes, when pressure was to be reduced by use of the manometer on Femostop, they were unable to do so. Pressure was reduced by loosening Femostop belt. No bleeding at site. Pedal pulses palpable. After 30 minutes Femostop was removed and a wedge dressing was applied as in hand-held protocol. After removal from the patient, the nurses were still unable to deflate the pressure pad on the Femostop. Cath checks were completed without bleeding or hematoma.

Device:
Type: Clamp, Vascular
Manufacturer: Maquet
Brand: Heartstring Iii Proximal Seal System
Model#: HSK-3038
Lot #: 25023772

Problem:
Scrub tech attempted to load the Heartstring III and it would not load properly.

Device 1:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673

Device 2:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673
Problem:
The surgeon attempted to tie down the Perclose sutures but the right side failed to seal. On the left side one suture went down and the other suture pulled out. The surgeon performed bilateral femoral artery cutdowns and proximal distal control was obtained on the common femoral profunda femoris and superficial femoral arteries and the arteriotomy was closed with multiple interrupted 5-0 Prolene sutures.


EAR, NOSE, & THROAT

Device 1:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM
Model#: NIM 2.0

Device 2:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM

Problem:
After the first surgery, surgeon #2 made a complaint to the OR manager stating that he wanted the NIM's checked out since the probe function was questionable during the procedure. He stated the patient could have nerve damage, but that the patient had promising signs of eye blinking. At that time it could not be identified which of two owned NIM's was used. Both NIM's were sent to our BioMed department who reported "Setup and tested both units per manufacturers checklist. All tests passed...no problems indicated." Neurosurgeon assessment after surgery #1 indicated right facial weakness. Surgeon #2 noted complete eye closure with effort, no nystagmus in primary or lateral gaze. Facial nerve had good prognosis. Since the complaint from surgeon #2 was made, we made a decision to keep both NIM's out of service until we could determine if the patient was affected. Surgeon #2 told us that he "feels" the patient was injured because of this NIM. He said he has problems with the old NIM's of the same model. He said he had just had a problem the day before at a neighboring children's hospital with the same model of the NIM's. He feels all the older NIMs are having issues. He said he reported multiple concerns from three other hospitals to Medtronic Representative. The surgeon said that all the problems were with the "old" equipment models and that other hospitals needed to buy the newer model as the new model is more "sensitive." Per neurosurgeon in discharge summary, the patient's discharge condition was improved. There is no way to definitely determine if the patient was impacted.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip
Model#: ER320
Other #: size M/L

Problem:
Operating staff report patient undergoing laparoscopic cholecystectomy. Upon the surgeon using the Ethicon Ligaclip Endoscopic Rotating Multiple Clip Applier the applier deployed too many clips with firing of the device. All clips accounted for but not retained. Surgeon utilized a different clip applier to finish the procedure. No injury or harm to the patient. Patient was sent to PACU for recovery. Original clip applier was removed from the field and sequestered for Risk Management pick up.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Vistec
Model#: 7318
Lot #: 100000071062

Problem:
Debris observed inside sterile package during room set-up. There was no patient impact.

See device image:

 Image of sponge gauze packaging with black speck within gauze.  Image also shows the outer packaging of the sponge gauze.  Outer packaging text is too small to read from image.




Device:
Type: Magnetic Pad
Manufacturer: Medical Action Industries Inc.
Model#: 200-20A
Lot #: 104649

Problem:
Magnets are pulling loose from fabric when pad is being opened. Pad removed from sterile field. Opened second pad and same thing happened again. Went without magnetic drape for this case. This appears to be a problem that is specific to this lot number. All applicable hospitals are pulling this lot number from service.

Device:
Type: Tissue Sealing Device
Manufacturer: Ethicon Endo-Surgery, Inc
Brand: Enseal
Lot #: 54RN53
Cat #: NSEAL545H

Problem:
During the surgery, it was noted that the black coating on the shaft of the EnSeal was peeling away. Product was removed from the surgical field and replaced immediately.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela Picc With Pasv Valve Technology
Model#: H965457350
Lot #: 4092320
Other #: order # 45-735

Problem:
Per the IV Team Nurse Manager: For the last five weeks we have been trialing the Navilyst PICC. Within the first two weeks of using the product we had concerns. Concerns were addressed with the firm as well as our support representative from the Navilyst company. The support representative worked with us to get us as successful as possible. Unfortunately, I regret to report that my team continues to have concerns for patient safety.

Over numerous occasions my team has encountered:
1. Bleeding at the catheter insertion site, requiring pressure dressings and sometimes removal of PICC.
2. With dressing changes it was found that scrubbing the site (per protocol) actually removed the ink markings on the catheter resulting in not being able to identify position/placement of PICC. (markings are centimeters that assist with the length of the catheter and how much is inside the patient's arm).
3. Two of my nurse's experienced missing ink markings after removal of the PICC line, questioning whether or not they got the PICC completely out.
4. Repeated lab draws due to erroneous values. (it was advised that our closed system technique could be the issue and it was recommended that we go back to syringe drawing)
5. Guide/Stiffening wires were getting kinked, coiled, or stuck in the patient.
Apparently other hospitals have been using the Navilyst PICC for sometime without issues. To my understanding another hospital has started their trial with the Navilyst PICC this week. For us at our hospital we will discontinue our Navilyst trial and return back to using AngioDynamics until we here further on the decision to consolidate with one company.


Device:
Type: Internal Transport Incubator/isolette
Manufacturer: International Biomedical
Brand: Airborne 750
Model#: A750i
Cat #: M1061999/731-0160

Lollipop Icon

Problem:
During transport of a neonate to another care area, the clinician smelled a strong electrical odor coming from the isolette on the side being pushed. The caregiver turned off the power to the isolette and transferred the infant to another isolette. The isolette was sent to biomedical for evaluation.

Device:
Type: Picc, Catheter
Manufacturer: BD Medical Systems
Brand: L-cath
Lot #: 0123897
Cat #: 384539
Other #: 26GA (1.9F) X 30cm

Problem:
While attempting to trim PICC line to correct length during an insertion procedure, the catheter line cutting block did not cut all the way through the catheter. Catheter tube only partially cut. A similar incident occurred the day before with a catheter from the same lot number. The user was attempting to trim the catheter using the supplied trim block tool included in the catheter kit. Catheter exchanged for new and insertion completed with no problem or issues. No patient harm during this sizing task.
======================
Manufacturer response for Peripherally Inserted Central Catheter [PICC], L-Cath
======================
Will ship back to mfg. in next two days

Device:

Type: Port, Catheter, Implanted
Manufacturer: Navilyst Medical
Brand: Xcela Power Injectable Port
Lot #: 101557000
Other #: REF H965451030

Problem:
RN in ER accessed patient's port with a power loc safety needle because he had a port-a-cath device card that indicated the port was a Xcela Power Injectable Port, suitable for IV contrast injection. RN used this card as identifier, but when patient went to CT, x-ray of chest was done as second identifier and the "CT" symbol that was supposed to be second ID was not on the port. This made the port unusable per our policy and since patient refused to have IV started for contrast, CT had to be done w/o contrast. Product is supposed to have this symbol on their ports suitable for use with IV contrast and with the power loc needle.
======================
Manufacturer response for Power Injectable Port, Xcela Power Injectable Port
======================
Per the Radiology APN:
The manufacturer was quite concerned that the CT was not visible. They have the lot number and are to be following up on that. They said they take it very seriously.


Device:
Type: Splittable Needle Introducer
Manufacturer: Becton Dickinson
Brand: Bd Splittable Needle Introducer
Lot #: Kit: 0266521; Needle: 0110590
Cat #: Kit Ref # 384516

Lollipop Icon

Problem:
Neonatal Nurse Practitioner (NNP) was placing a peripherally inserted central catheter (PICC). The needle was inserted with good blood return. The catheter placed and the needle withdrawn. This is a break away needle. The NNP attempted to break away the needle and part of the plastic remained at the junction of the needle and the hub resulting in the inability to remove the needle from the PICC. Attempts were made to break away the needle. The end result was that the catheter needed to be removed and another attempt made which was successful. The harm to the infant was a second needle stick for the placement of the PICC. A similar event with same device filed last fall.
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Manufacturer response for Splittable Needle Introducer, BD Splittable Needle Introducer; Kit Name: BD L-Cath PICC
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The Manufacturer has made arrangements to pick up the device.


NEUROLOGY

Device 1:
Type: Router Foot Plate
Manufacturer: The Anspach Effort, Inc
Brand: Anspach
Model#: CRANI-A

Device 2:
Type: Spiral Router
Manufacturer: The Anspach Effort, Inc
Brand: Anspach
Model#: 2.15mm x 22 mm fluted spiral router
Lot #: D533043246
Cat #: A-CRN-S

Problem:
During routine craniotomy, the spiral router drill bit broke while turning the cranial flap. 2 separate pieces of drill bit were accounted for. A second bit broke on the same day, different room, different surgeon, same lot number. When the bits break, there is always the possibility of a small fragment being left behind. They normally x-ray the patient to look for pieces, but a very small piece could be missed. There is a high likelihood these patients will need a MRI at some point in the future and the router material is highly magnetic, which could pose a safety problem. At the very least, there is a delay in the case while they look for the pieces.

In-house evaluation of the broken bits shows they both broke at the same location. We have had previous breakage problems with this type of bit. There may be an issue with the hardening process and/or the shape of the flutes that contributes to the breakage problem. Photos available.

Of note, the foot plate involved was checked and it seemed to be in perfect condition. (The foot plate is a re-usable part that protects the dura from the tip of the router bit during use. The foot plate contains a set of bearings that guide the router shaft).

See device images:

 Close up image of broken spiral router drill bit.  2 separated pieces of drill bit are shown in this picture.

 Close up image of broken spiral router drill bit.  Image shows 2 separated pieces of drill bit next to a ruler.  There is approximately 1 centimeter between the 2 separated pieces of drill bit.

 Zoomed out image of broken spiral router drill bit next to ruler.  Image also shows the foot plate used during the craniotomy next to the broken spiral router drill bit.  The foot plate is in perfect condition.


ORTHOPEDIC

Device:
Type: Trocar Drill Guide
Manufacturer: Stryker Instruments
Brand: Trocar Drill Guide
Model#: 62-02000
Cat #: 62-02000

Problem:
After surgery, patient was noted to have a burn on the cheek where it was in contact with the drill guide.

A similar incident occurred on several months ago with the same device.

The device was tested later and was noted to get extremely hot very quickly if the drill is pushed against the stop. There is a shoulder on the drill bit that makes contact with a stop near the tip of the drill guide. Drill console defaults to 40,000 rpm on startup. Manufacturer recommends a maximum speed of 25,000 rpm for this device.

Similar devices from other manufacturers make contact on non-rotating surfaces, so they cannot generate heat. Suspect devices have been removed from service. Device photos available.

See device image:

 Image of trocar drill guide and its components


RADIOLOGY

Device:
Type: Catheter, Brachytherapy, Breast
Manufacturer: Hologic, Inc.
Brand: Cytyc Mammosite
Lot #: 10D23R
Cat #: REF #2456
Other #: Size 4-5

Problem:
Patient was in for surgery for breast lumpectomy, sentinel node dissection/Possible Axillary Node Dissection/Placement of Mammosite Catheter. Pt had to return to surgery a week later for exchange of mammosite catheter due to "defective device". Progress note states "balloon asymmetry preventing PBRJ planning" (this would be radiation therapy planning). The balloon was intact, but deemed asymmetrical, hence needing replacement.


Device 1:
Type: Imaging Coil, Mri, Knee
Manufacturer: Siemens Medical Solutions USA, Inc.

Device 2:
Type: Mri System, 1. 5t
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Symphony Tim

Problem:
Patient was pre-screened to make sure he was MRI safe, and that there were no metal implants in his body or on his person. He was brought into the MRI scan room. He was wearing a sweatshirt, shorts and his socks. He was positioned with his left knee in the knee coil and his right leg was wrapped in the cloth RF blanket. During the 4th sequence the technician heard yelling. There was a radio on in the room for the patient, so the tech didn't realize it was the patient until he started flailing his arms. The tech immediately stopped the scan and turned the intercom on to ask if he was ok? The patient felt he was on fire. The tech ran into the scan room, fed the table out, and as she pulled it out, she saw smoke. The tech grabbed the RF blanket, threw it on the floor, noticing that it had a burn hole in it and was still orange around the ring. She got the top of the knee coil off, and after the patient sat up, she took his sock off, which was burned. She grabbed a washcloth with cool water and put it on the burned area on his leg, and wrapped that with Coban to keep it on. The other tech called security, the supervisor and EC, and Siemens (the manufacturer of the MRI). The 1st tech took the patient by wheel chair to the EC. While on the way to the EC patient stated that during the scans he felt warm in the leg area and moved his leg a little and it was ok. But it continued to get warm and then proceeded to get hot until it was unbearable. He knew from previous MRIs, that you can experience warmth. The tech examined his sock to see if there was anything on the sock that may cause it to catch fire, but nothing was visible. The patient had a burn on his leg. The area looked yellow. There was nothing worn or damaged on the whole top part of the knee coil input plug and coil-cord/ tail. The RF Blanket was later analyzed, and it appears that it is lined with a copper material, that frayed or possibly wrapped around itself to create a conductor that heated up during the MRI scan.

Device:
Type: Radiology Room
Manufacturer: Siemen's Medical Solutions USA, Inc.
Brand: Axiom Luminos
Model#: 2000132

Problem:
Pelvic films were taken on a patient. The techs went to pull the images up and the machine brought up an error message. Could not find the images on the machine and the images were repeated. What is the health professional's impression of how the device may have caused or contributed to the adverse event? Images were taken on the machine; we were unable to retrieve those images. Images had to be repeated.

Device:
Type: Software, Radiation Therapy
Manufacturer: Impac Medical Systems, Inc.
Brand: Impac, Multi Access Version 6. 10 G4

Problem:
IMPAC device lost communication during the delivery of 123 mu's. Impac stated 35 remained when the LINAC computer displayed 45, which was the accurate number. The very observant therapists noticed the discrepancy and delivered the correct dose. The patient was not harmed.

It appears that a software upgrade resolved this issue.


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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problems With Ultrasonic Surgical Instruments

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Ultrasonic surgical instruments are sterile single patient use instruments consisting of a pistol grip housing assembly and, in some cases, hand control buttons on the housing of the instrument. The instruments have a rotating shaft with a curved blade and a clamp arm and pad, and are designed to work through a trocar with appropriate fittings, or through an incision without the use of a trocar. The instruments are available in a number of shaft lengths. (510(k) Summary, 2006)

The instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures. (510(k) Summary, 2006). Some devices of this type may have customized designs, such as a shorter length shaft and is specifically intended for use in otorhinolaryngology procedures. (510(k) Summary, 2007).

Ultrasonic surgical instruments are designed to be used with a specific generator capable of providing electrical energy for the system. A reusable cable or hand piece then converts the electrical energy from the generator to mechanical energy, allowing the device to function.

In addition to original device manufacturers, some third party reprocessing firms have been cleared to reprocess single use ultrasonic surgical instruments. (List of Single-Use Devices, 2010)

Over the past 6 months, MedSun has received 41 adverse event reports associated with ultrasonic surgical devices reprocessed or originally manufactured by Ascent Healthcare Solutions or Ethicon Endo-Surgery, Inc., The reports were submitted by 25 hospitals between December 2010 and May 2011.

The reported device problems were (note that some reports contained multiple problems):

•27 reports describe device being inoperable, intermittent or ineffective
•10 reports involve breakage and/or detachment of a device component
•5 reports involve smoking / overheating of the device
•4 reports describe other miscellaneous complaints

No reports involved a patient death. The patient problems listed below were reported in these 41 reports.

•All 41 problems resulted in possible prolonged surgery due to troubleshooting or need to replace device
•6 reports involve retrieval of a device fragment
•2 reports involve possible retained device fragment(s)

Of the reports that listed patient age, one (1) had a patient age listed as less than 21 years and 33 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 27 reports involved female patients and a total of 8 reports involved male patients.

The MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, NA During a ruptured ectopic pregnancy case, two different reprocessed harmonic scalpels and two different cords were used in an attempt to perform a laparoscopic salpingectomy. Neither of the cords, or scalpels worked. At this point, brand new harmonic long shears were used with one of the cords previously attempted and it worked well. No further problems were encounter. There was no patient injury, but the surgical procedure was prolonged.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, 1270964 While using the harmonic scalpel hand piece for a sympathectomy, the hand piece would malfunction periodically. It would then function for a few more minutes, then require resetting again. This malfunction would necessitate the restarting of the machine. The surgery was completed with this equipment and no harm was done to the patient.
Ascent Healthcare Solutions
Ethicon Harmonic Scalpel
LCSC5, NA, 1311474 Harmonic scalpel was working for about 10 minutes then the console alarmed saying there was an instrument problem. After checking all connections it still was not operational. A second scalpel was used to complete the procedure.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KP0L A patient was undergoing a laparoscopic Roux-en-Y gastric bypass and the harmonic scalpel "curved shears with ergonomic handle hand control and torque wrench" were being used. The surgeon stated it was working intermittently and desired to switch the hand pieces out. No harm came to patient per surgeon. The defective harmonic hand piece was removed from the field and given to manager to follow up. The replacement harmonic worked correctly.
Ethicon Endo-Surgery, Inc.
Harmonic Scalpel
NA, NA, NA The patient was having a robotic assisted total laparoscopic hysterectomy. While the physician was using the harmonic scalpel robotically, the tip of the instrument broke off. It was immediately identified and retrieved from the patient.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1467928 ACE harmonic hand piece (reprocessed) worked intermittently for a short while. It kept freezing up. Replaced with new original ACE harmonic hand piece and it did not fail.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1510331 "The surgeon engaged the harmonic scalpel hand piece. Once the tissue was cauterized, and the surgeon had removed his hand from the trigger, the hand piece continued to fire. The OR staff pushed the hand activation button on unit to disable and turned machine off.

Ascent would like to obtain device for inspection and testing.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, H90491 A patient was undergoing laparoscopic surgery to remove splenic cyst. The curved shears overheated, and the clamp arm/active blade broke. A portion of it (approximately 6 mm) dropped into the patient's abdomen and it was not retrieved. The CUT and COAG settings on the ESU were 30. There was no patient harm.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LFOT During an endometriosis procedure, the device (harmonic ACE curved shears) stopped working while dissecting/cutting tissue. The device was retested and still failed to operate. It was replaced by an identical unit that worked without problem. Staff noted that the tissue being cut was thick and tenacious. It is unknown if that factor contributed to the failure.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS MAX
FCS9, NA, H4312J The surgical team were plugging in equipment, including the harmonic scalpel for an open heart case of a prepped and draped patient. When the harmonic scalpel was turned on, it failed its test multiple times. The machine was switched out without luck, as it still did not work. A different cord was tried, again with no luck. The a different hand piece was tried and it worked. Once surgeon was finished with harmonic scalpel, it was taken off the field, tested all cords, disposable hand pieces and machines and everything worked fine. The Ethicon representative was called
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, G4RJOH During an open heart case, the team was getting the suction, cattery and harmonic plugged in before the case had started. Nurse tried to test the harmonic and it showed a hand piece error even after multiple tests. Switched out the blue cable but to no avail, then switched out the hand piece and it worked.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
ACE36E, NA, NA White tip of the harmonic scalpel fell off inside the abdomen. It was retrieved by physician with no harm to the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9L10H Harmonic ACE hand control curved shears were being used by surgeon when the tip began to smoke. The Ethicon representative was in house at the time of the event and took the hand piece.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, G9LL2R 105 Harmonic focus FCS9 curved shears failed to work near the end of case. Shears taken off field to be examined by the representative.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, NA Harmonic curved shears did not work. They tested ok, but when surgeon attempted to use the shears on the patient, they would not fire. A second set was opened and they did not work. The industry representative was notified.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, H90C4U During a laparoscopic supracervical hysterectomy a piece of a disposable ACE harmonic scalpel blade (shear tip) broke off inside the abdomen. After a thorough search the piece was retrieved without harm to the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, LOTS: G9LF0W; E4MC3T; F4NW8J; F9JO8A "II have 5 harmonic scalpels that where sent to me with complaints of pads falling off, quitting mid procedure, or not operating. Please note the incidents happened among multiple surgeons who are very familiar with the device.

Patient 1 - laparoscopy, resection of pelvic endometriosis, the first harmonic placed on the field would not work at all (package thrown out), second harmonic was working, then stopped and the ends were burnt off.

Patient 2 - laparoscopy resection of endometriosis. Harmonic scalpel stopped working in middle of case.

Patient 3 - reduction of hiatal hernia and repair of diaphragmatic defect. Tip broke off harmonic scalpel during procedure. Tip not found.

Patient 4 - laparoscopic supracervical hysterectomy. Tip broke off harmonic scalpel.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1437267 The doctor was using a harmonic scalpel during procedure and the tip fell off inside the patient's abdomen.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 43129136 Tip of scalpel started to peel away.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1359662 The harmonic scalpel would not accept the attachment cord. Another cord was opened and the scalpel still would not accept it.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1429166 Doctor was attempting to use the device and the machine alarmed "Alert Handpiece".
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, 1458304 When depressing button it was not working properly. It was only working intermittently.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1469421 The product's handle was split prior to being opened. The ACE was never used on the patient.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1352835 Device was being set up for use and would not work.
ETHICON ENDO-SURGERY, INC.
HARMONIC ACE
ACE36E, NA, G9L80M The physician was using the device and it stopped working from the hand controls. He then continued by using the foot pedal. The representative from Ethicon inspected the unit but was unable to reproduce the problem; as it maybe an intermittent issue. Et
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1363829 The device stopped working during procedure. Ascent was informed of the problem and asked to speak to the OR staff. Ascent representative will send a return label and provide packaging to return the product.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1285164 Product worked intermittently.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, LOTS: 1288382 AND 1341660 There were two ACE36E instruments. One did not work and the other worked for 15 minutes and then stopped. A problem with the switch was reported.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KE9M Hand control was not working. A malfunction of the switch was reported.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, LOTS: G9KZ4Y AND G9L251 Hand control would not work: switch malfunction.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LG4L During an operative laparoscopy performed by the doctor, a harmonic scalpel hand piece was used. While being used intra abdominally, some of the insulation on the tip of the harmonic scalpel broke off the instrument and was seen lying inside the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KY8Z Disposable harmonic blade tips would not grip the tissue and had to be replaced.
Ascent Healthcare Solutions
Harmonic FOCUS
FCS9, NA, 1323355 While using a reprocessed harmonic device, it stopped working during the case. The machine was shut off and the device was tightened again. Later during the case it became activated and warm while in the doctor's hand. The doctor was not pressing the handle. It was replaced with a new item using the same cord and machine. Machine and cord were checked after case and no problems were found.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE45E, NA, G4TV8N The Harmonic ACE (Long 45) malfunctioned. A bad connection between the cord and the hand piece device was reported. The product was sequestered immediately and given to supervisor.

Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1355761 Could not get device to work at all.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LK4K The device melted fat tissue but did not seal blood vessels.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9L21F Device was working for portion of the case and then stopped altogether.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE23E, NA, G4RC9V Device was used on and off for about one (1) hour on bowel tissue. After one (1) hour, the machine gave trouble alert and display requested new instrument. An attempt was made to tighten the instrument and reattach cords without success. New instrument was then opened and used to finish case. No patient harm.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1154063 On high, the device "stuttered" and did not perform.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KX8R Device would not accept cord. Threads not working. Cord worked on new hand piece.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LK60 While performing a laparoscopic cholecystectomy, the harmonic scalpel was noted to have the white padding frayed during use. Original harmonic scalpel removed from the patient with the pad. A new harmonic scalpel was obtained to finish procedure. There were surgical delays and a good patient outcome. It was reported this event is not uncommon to Ethicon. If the device is fired with the jaws closed for an extended period the white pad melts and it can become dislodged.

Ethicon will send box to return the device to them and they will test it.

Additional Information:

List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing. US Food and Drug Administration. March 2009.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121218.htm

Harmonic Scalpel Blades and Shears 510(k) Summary. January 2006.

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053056.pdf

Harmonic FOCUS Shears 510(k) Summary. April 2010. Retrieved from:

http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100597.pdf

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Updated June 1, 2011

Return to MedSun: Medical Product Safety Network

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