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	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and faire 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 the following: do 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
Update: a good faith attempt to gather more information was completed; however, to date no reply has been received.The customer reported that the device, aes-90sn arthroscopic energy 90° probe with suction, 13 cm was being used on (b)(6) 2025 and "during hip arthroscopy, 2 foreign bodies were noted on x-ray.One of the threads was removed - 1/3 of the metal tip of the vaporizer.The other could not be located arthroscopically - it was left in the tissues.Damage to 2/3 of the vaporizer tip was found, and it was disposed of.¿ there was no impact or injury to the patient or user.The procedure was completed without an alternate device.There was a 45 minute delay to the procedure.This report is being raised on the basis of injury due to patient retaining a fragment of the device.
Event or Problem Description
The customer reported that the device, aes-90sn arthroscopic energy 90° probe with suction, 13 cm was being used on (b)(6) 2025 and "during hip arthroscopy, 2 foreign bodies were noted on x-ray.One of the threads was removed - 1/3 of the metal tip of the vaporizer.The other could not be located arthroscopically - it was left in the tissues.Damage to 2/3 of the vaporizer tip was found, and it was disposed of.¿ there was no impact or injury to the patient or user.The procedure was completed without an alternate device.There was a 45 minute delay to the procedure.This report is being raised on the basis of injury due to patient retaining a fragment of the device.
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.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 3157978375
• MDR Report Key: 21925349
• Report Number: 1320894-2025-00125
• Device Sequence Number: 15635444
• Product Code: GEI
• UDI-Device Identifier: 10653405006473
• UDI-Public: (01)10653405006473(17)280911(10)202311101
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 06/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AES-90SN
• Device Lot Number: 202311101
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic