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

Catalog Number	60-5163-001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-5163-001, laparoscopic electrode with a 3/32" pin connector, l-hook was being used on (b)(6) 2024 during a laparoscopic procedure and ¿the coating/insulation on the lhook had come off.¿ per further assessment it was found that "no fragment fell into the surgical site." there was no impact or injury to the patient.There was no delay to the procedure.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 per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Examination of returned used device 60-5163-001 found that there was no insulation on the l hook.The root cause cannot be determined, however, based upon evaluation and ifu, the likely cause of this event was excessive force that caused the device to become damaged.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 1 report, regarding 1 device, for this device family and failure mode.During this same time frame 270,540 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 0.000004.Per the instructions for use, the user is advised the following: follow all manufacturer¿s guidelines for electrosurgical safety.Always use the lowest possible power setting to achieve the desired electrosurgical effect do not activate the electrosurgical unit until the tip of the instrument is touching the target tissue, or in very close proximity to it in the instance of fulguration (spray coagulation).Do not activate the electrosurgical unit if you cannot clearly see the position of the instrument tip with respect to all surrounding tissues and structures.Do not activate the electrosurgical instrument if the tip of the instrument is within the trocar cannula.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 the 60-5163-001, laparoscopic electrode with a 3/32" pin connector,l-hook was being used on (b)(6) 2024 during a laparoscopic procedure and ¿the coating/insulation on the lhook had come off.¿.Per further assessment it was found that "no fragment fell into the surgical site.".There was no impact or injury to the patient.There was no delay to the procedure.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20891656
• Report Number: 1320894-2024-00424
• Device Sequence Number: 8676026
• Product Code: HFG
• UDI-Device Identifier: 30653405009768
• UDI-Public: (01)30653405009768(17)290721(10)202407221
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K904240
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 202407221
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic