MAUDE Adverse Event Report: CONMED ABC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	160656
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the abc probe 5 mm handswitching probe, 28 cm device was being used during a robotic lap liver resection procedure on (b)(6) 2025 when it was reported ¿plastic sheath on distal end of device was melted and cracked.One small piece was retrieved from the patient¿s abdomen¿.There was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the 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 the abc probe 5 mm handswitching probe, 28 cm device was being used during a robotic lap liver resection procedure on 18dec25 when it was reported ¿plastic sheath on distal end of device was melted and cracked.One small piece was retrieved from the patient¿s abdomen¿.There was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised on 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 one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 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 that before use, inspect the cord insulation and handpiece integrity and condition.If damaged, chipped, cut, or nicked, do no use the handpiece/probe.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: ABC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24057268
• Report Number: 3007305485-2026-00005
• Device Sequence Number: 9707169
• Product Code: GEI
• UDI-Device Identifier: 30653405003896
• UDI-Public: (01)30653405003896(17)260225(10)202102264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K925903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 02/25/2026
• Device Catalogue Number: 160656
• Device Lot Number: 202102264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic