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	Arcing (2583)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence was provided; therefore, a root cause cannot be identified.A two-year lot history review was conducted and found a total of 2 similar events involving 2 devices for this lot number.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 review of complaint history revealed there has been a total of 3 reports, regarding 3 devices, for this device family and failure mode.During this same time frame 336,775 devices 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 0.000009.Per the instructions for use, the user is advised the following: misuse of this or any other electrosurgical device can result in a patient injury.Read and become familiar with all instructions and directions before using this device.Do not use these or any electrosurgical instrument with a cable that does not make good, secure contact with the electrosurgical adaptor of the instrument or the electrosurgical generator.If in doubt about the compatibility of a cable from another manufacturer, consult your hospital biomedical engineer.Examine this device prior to use for damage.Do not use if damage is found.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-5274-132, stealth 32 lhook lap elec pkg was being used on approximately (b)(6) 2022 during a lap chole and the device was reported as ¿sparking and burning through the l-hook black shaft.It ends up burning the liver.¿.Further assessment found, they were using the l hook to ¿dissect the gallbladder from the liver.While we were working, we noticed an arc from the l hook sheath to the liver which caused a burn.¿ the burn was 2nd degree.The patient was reported as recovering well and there was no extended stay at the hospital.The procedure was completed, ¿except for the burns to the liver from device.¿.The electro surgical unit used was the olympus and the settings were 35.There was no delay to the procedure.There was no allegation against the 60-6010-005, universal plus straight-rocker and it will be listed as a concomitant device.This report is being raised on the basis of injury due to 2nd degree burn.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13584000
• Report Number: 1320894-2022-00044
• Device Sequence Number: 4369074
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)261003(10)202110041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2026
• Device Model Number: 60-5274-132
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202110041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic