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

Catalog 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	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of the customer that the 60-5274-132-stealth 32 lhook lap elec pkg was being used on (b)(6) 2023 and the ¿insulation part of the electrode seemed to have fuzz looks like peeling.¿ there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with an alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Additional Manufacturer Narrative
Received one 60-5274-132 in unoriginal packaging.Lot number was not verified.Performed a visual inspection, the black insulator on the electrode is frayed 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding 14 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).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.During trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and the electrode tip.Examine this device prior to use for damage.Do not use if damage is found.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of the customer that the 60-5274-132-stealth 32 lhook lap elec pkg was being used on (b)(6) 2023 and the ¿insulation part of the electrode seemed to have fuzz looks like peeling.¿ there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.The procedure was completed with an alternate device.This report is being raised due to the reported 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17792136
• Report Number: 1320894-2023-00189
• Device Sequence Number: 7433607
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)280401(10)202304031
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 60-5274-132
• Device Lot Number: 202304031
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic