MAUDE Adverse Event Report: CONMED UTICA 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	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the aes-50sl, arthroscopic energy 50° probe with suction, xl, 18 cm, device was being used in a hip arthroscopy procedure on (b)(6)2024 when it was reported, ¿while using the bipolar edge device, it suddenly stopped functioning.Upon inspection, the surgeon discovered that the tip of the bipolar device had broken off inside the patient.Using fluoroscopy, the surgeon was able to locate and retrieve the broken tip from the joint.Fortunately, no harm was caused to the patient, and the procedure was completed without further complications.¿.The procedure was completed with the use of the same alternate device and a 2-minute delay was reported.There was no report of injury, medical intervention, or extended hospitalization for the patient.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.
Additional Manufacturer Narrative
Reported event ¿tip of the device had broken off¿ was confirmed.Examination of the returned used device, item aes-50sl found electrode tip detached, broken off from the device shaft.Root cause cannot be determined, however, based upon evaluation of the device, photos, and the ifu; a possible cause of this event could be 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.(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 customer reported that the aes-50sl, arthroscopic energy 50° probe with suction, xl, 18 cm, device was being used in a hip arthroscopy procedure on (b)(6) 2024 when it was reported, ¿while using the bipolar edge device, it suddenly stopped functioning.Upon inspection, the surgeon discovered that the tip of the bipolar device had broken off inside the patient.Using fluoroscopy, the surgeon was able to locate and retrieve the broken tip from the joint.Fortunately, no harm was caused to the patient, and the procedure was completed without further complications.¿.The procedure was completed with the use of the same alternate device and a 2-minute delay was reported.There was no report of injury, medical intervention, or extended hospitalization for the patient.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 UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 20999716
• Report Number: 1320894-2024-00444
• Device Sequence Number: 18608699
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)251111(10)202405151
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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 Expiration Date: 11/11/2025
• Device Catalogue Number: AES-50SL
• Device Lot Number: 202405151
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: XRAY; XRAY
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic