MAUDE Adverse Event Report: CONMED UTICA CONMED; COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Catalog Number	60-5163-001
Medical Device Problem Codes	Material Fragmentation (1261); Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that 60-5163-001, laparoscopic electrode with a 3/32" pin connector,l-hook device was being used during an open procedure on 30apr25 when it was reported ¿the plastic part of the l-hook was melting.¿.Further assessment was attempted, and a good faith effort was completed, however, to date no further information is available.The procedure was completed with no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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 shows a total of 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 7 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 to use only with electrosurgical units that comply with iec 60601-1 standards.Do not exceed the maximum electrical capacity of the device.Maximum rated voltage is 2000 vp.8.Select the desired setting for cut or coagulation on the electrosurgical unit.Always use the lowest possible power setting to achieve the desired level of cutting or coagulation of the tissue.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
Update: further assessment information reported that "melted plastic fell into the patient when it melted off during use.A laparoscopic maryland was used to pick up and remove the melted plastic".The sales representative reported on behalf of the customer that 60-5163-001, laparoscopic electrode with a 3/32" pin connector, l-hook device was being used during a laparoscopic hysterectomy procedure on (b)(6) 2025 when it was reported ¿the plastic part of the l-hook was melting.¿ further assessment was attempted, and a good faith effort was completed, however, to date no further information is available.The procedure was completed with no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
Update: further assessment information reported that "melted plastic fell into the patient when it melted off during use.A laparoscopic maryland was used to pick up and remove the melted plastic".The sales representative reported on behalf of the customer that 60-5163-001, laparoscopic electrode with a 3/32" pin connector,l-hook device was being used during a laparoscopic hysterectomy procedure on (b)(6) 2025 when it was reported ¿the plastic part of the l-hook was melting.¿.Further assessment was attempted, and a good faith effort was completed, however, to date no further information is available.The procedure was completed with no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of ¿melted plastic fell into the patient¿ was confirmed.Examination of returned used 60-5163-001 device found that the black material covering the tip of the electrode had melted away and the ends were left frayed.A root cause cannot be determined; however, based upon evaluation of the device, a likely cause of this suspected failure is user related.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.(b)(4).Per the instructions for use, the user is advised to use only with electrosurgical units that comply with iec 60601-1 standards.Do not exceed the maximum electrical capacity of the device.Maximum rated voltage is 2000 vp.8.Select the desired setting for cut or coagulation on the electrosurgical unit.Always use the lowest possible power setting to achieve the desired level of cutting or coagulation of the tissue.This product is designed for non-continuous operation, with a duty cycle of 10 seconds on, and 30 seconds off.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 22110342
• Report Number: 1320894-2025-00144
• Device Sequence Number: 15512042
• Product Code: HFG
• UDI-Device Identifier: 30653405009768
• UDI-Public: (01)30653405009768(17)291006(10)202410071
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2025

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: 60-5163-001
• Device Lot Number: 202410071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 09/08/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/01/2025; 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic