MAUDE Adverse Event Report: CONMED UTICA STEALTH 32 LHOOK LAP ELEC PKG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-5274-132
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
Event or Problem Description
Conmed (b)(4) reported on behalf of their customer that the 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a laparoscopic uterine myomectomy procedure on (b)(6) 2022 when it was reported that, ¿about 1 hour after the start of operation, the insulating coating on the electrodes broke and became hangnail-like and adhered to the tip.¿ the procedure was completed using an alternate unknown device and there was no time delay for the surgery.Further assessment questioning found that the obstetrician-gynecologist was the initial reporter, the device was in the sterile field when it broke however the device did not fragment and the device did not fall into the surgical site.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-5274-132 in opened original packaging.Lot number was verified.Performed a visual inspection, the black insulation is split apart and peeling.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to examine the device prior to use for damage.Do not use if damage is found.Should eschar adherence occur on the 60-5272 series, the electrode tips can be cleaned with an electrosurgical scratch pad.On the 60-5274 series, with eschar-resistant coating, any adhering can be easily wiped away with a sterile, moistened sponge.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.Always use the lowest possible setting to achieve the desired electrosurgical effect.Misuse of this or any other electrosurgical device can result in a patient injury.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a laparoscopic uterine myomectomy procedure on (b)(6) 2022 when it was reported that, ¿about 1 hour after the start of operation, the insulating coating on the electrodes broke and became hangnail-like and adhered to the tip.¿ the procedure was completed using an alternate unknown device and there was no time delay for the surgery.Further assessment questioning found that the obstetrician-gynecologist was the initial reporter, the device was in the sterile field when it broke however the device did not fragment and the device did not fall into the surgical site.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14250020
• Report Number: 1320894-2022-00088
• Device Sequence Number: 4887010
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)261219(10)202112201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-5274-132
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202112201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic