MAUDE Adverse Event Report: CONMED UTICA ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AES-50SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2023
Type of Reportable Event	Serious Injury
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the aes-50sl, arthroscopic energy 50 degree probe with suction 18 cm device was being used during a hip arthroscopy surgery on (b)(6) 2023, and ¿the face of the electrode broke while it was being used.The surgeon try to removed the tip but it was not possible.After they check it they decided to keep into the patient.¿.The procedure was completed with ¿another edge probe¿ and with a delay of 10 minutes.There was no report of further medical intervention or extended hospitalization for the patient.This report is being raised on the basis of injury due to fragmentation with retained foreign body.
Event or Problem Description
A sales representative reported on behalf of a customer that the aes-50sl, arthroscopic energy 50 degree probe with suction 18 cm device was being used during a hip arthroscopy surgery on (b)(6) 2023, and "the face of the electrode broke while it was being used.The surgeon try to removed the tip but it was not possible.After they check it they decided to keep into the patient." the procedure was completed with "another edge probe" and with a delay of 10 minutes.There was no report of further medical intervention or extended hospitalization for the patient.This report is being raised on the basis of injury due to fragmentation with retained foreign body.
Additional Manufacturer Narrative
Reported event ¿electrode broke while it was being used¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; 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.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ARTHROSCOPIC ENERGY 50 DEGREE PROBE WITH SUCTION 18 CM
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18475755
• Report Number: 1320894-2024-00007
• Device Sequence Number: 6784819
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)240603(10)202212061
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2024
• Device Catalogue Number: AES-50SL
• Device Lot Number: 202212061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic