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

Catalog Number	AES-90SN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer reported that the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm device was used in an arthroscopic left shoulder cuff repair procedure on (b)(6) 2025, and ¿during acromial cleaning (arthroscopy), breakage of a metal piece 3 mm piece of metal from the electrocoagulation probe lodged in the patient's deltoid muscle (seen in the intraoperative x-ray).No conflict with adjacent structures, so not removed.Probe changed." the procedure was completed with "another probe" and a delay of 1 hour.Further details have been requested but have not been made available to date.This report is being raised due to the reported injury of a retained foreign body.
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 per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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.A two-year lot history review shows a total of (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 56 reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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
A customer reported that the aes-90sn, arthroscopic energy 90° probe with suction, 13 cm device was used in an arthroscopic left shoulder cuff repair procedure on (b)(6)2025, and ¿during acromial cleaning (arthroscopy), breakage of a metal piece 3mm piece of metal from the electrocoagulation probe lodged in the patient's deltoid muscle (seen in the intraoperative x-ray).No conflict with adjacent structures, so not removed.Probe changed.¿.The procedure was completed with ¿another probe¿ and a delay of 1 hour.Further details have been requested but have not been made available to date.This report is being raised due to the reported injury of a retained foreign body.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21355983
• Report Number: 1320894-2025-00042
• Device Sequence Number: 21070477
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)280911(10)202309131
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 Catalogue Number: AES-90SN
• Device Lot Number: 202309131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic