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	03/24/2026
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
A sales representative reported on behalf of a customer that the aes-50sl, arthroscopic energy 50° probe with suction, xl, 18 cm device was used in a hip arthroscopy procedure on (b)(6) 2026, and ¿during the procedure, the surgeon used a bipolar device, and the black electrode tip detached as the instrument was withdrawn from the patient.The tip subsequently lodged in the patient¿s soft tissue, resulting in an additional 20 minutes of operative time to allow for its localization and safe removal.As the surgeon was searching for the black tip of the bipolar device, fluid extravasation occurred into the soft tissues, resulting in more pronounced swelling of the thigh.¿.The procedure was completed without the use of an alternate device.Further assessment found "the fluid originated from the intra-articular saline solution.The fluid extravasation due to the prolonged duration of the surgery; it is not considered an injury, but rather a consequence of the issue related to the lost tip.No injury was diagnosed.No additional medical or surgical intervention was required, and no extended hospitalization was necessary.The patient is currently doing well.No other relevant information is available regarding this incident.¿.This report is being raised on the basis of 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24927187
• Report Number: 1320894-2026-00107
• Device Sequence Number: 10728098
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)270606(10)202512081
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 202512081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female