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	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 customer reported that the that the 160656 abc probe 5 mm handswitching probe, 28 cm, device was being used on (b)(6) 2026 during a thoracotomy procedure when it was reported ¿tip of device fell off device into open chest cavity.¿.Further assessment questioning confirmed that the fragment was removed from the surgical site.The procedure was completed and there was no report of injury, medical intervention or extended stay for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 25275975
• Report Number: 3007305485-2026-00116
• Device Sequence Number: 9157515
• Product Code: GEI
• UDI-Device Identifier: 30653405003896
• UDI-Public: (01)30653405003896(17)310104(10)202601054
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K925903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 06/11/2026

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 Catalogue Number: 160656
• Device Lot Number: 202601054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown