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

Catalog Number	AES-50SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned used device, item aes-50sl found electrode tip detached, broken off from the device shaft.Examination was performed by edge probes, standard work line #1, mp-09-1770, rev av.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be use of excessive force.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.(b)(4).Per the instructions for use, the user is advised to not use the probe for mechanical displacement of tissue, damage to the probe may occur.Do not activate the probe while any portion of the active or return electrode is in contact with another metal object, including the scope; localized heating of the electrode and the adjacent metal object may result in product damage and/or injury.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 device, aes-50sl, arthroscopic energy 50° probe with suction, xl, 18 cm, was being used during a hip arthroscopy procedure on (b)(6) 2025 when it was reported, ¿during the surgery, the surgeon used the bipolar device, and the black tip of the electrode detached from the device¿s tip when it was removed from the trocar.¿.Further assessment was requested from the reporter and they stated, ¿it broke inside the patient, and the break was visualized through the camera.The tip was damaged but still attached to the handle.Once the instrument was removed from the patient, the tip fell onto the floor.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 2-minute delay without 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 per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, aes-50sl, arthroscopic energy 50° probe with suction, xl, 18 cm, was being used during a hip arthroscopy procedure on (b)(6) 2025 when it was reported, ¿during the surgery, the surgeon used the bipolar device, and the black tip of the electrode detached from the device¿s tip when it was removed from the trocar.¿.Further assessment was requested from the reporter and they stated, ¿it broke inside the patient, and the break was visualized through the camera.The tip was damaged but still attached to the handle.Once the instrument was removed from the patient, the tip fell onto the floor.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with a 2-minute delay without an alternate device.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: CONMED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23815393
• Report Number: 1320894-2025-00283
• Device Sequence Number: 10006392
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)270303(10)202509041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: AES-50SL
• Device Lot Number: 202509041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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: Female
• Patient Ethnicity: Non Hispanic