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

Catalog Number	AES-50S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, aes-50s, arthroscopic energy 50° probe with suction, 13 cm, was being used during a hip scope procedure on (b)(6) 2025 when it was reported, ¿during a hip arthroscopy, the tip of a conmed 50 degree rf wand became loose.It was swapped out for another 50 degree wand which was used to finish the case.Immediately after it was discovered by x-ray that the tip of the wand remained inside the patient.Following this procedure a ct scan will be used to evaluate whether the tip remains in the joint or if it is in soft tissue.¿.Further assessment questions found that the fragmentation was not retrieved the day of surgery but was removed the next day ((b)(6) 2025) in a secondary surgery.This report is being raised due to the reported injury of secondary surgery required to remove component.
Additional Manufacturer Narrative
Additional lot number given: 202506101 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
Additional lot number given: 202506101 the device will not be returned for evaluation, however, photographic evidence has been provided.Root cause cannot be determined, however, based upon provided photos; a possible cause of this event could be excessive force.A two-year lot history review shows a total of one (1) device for this lot number and failure mode.A device history record (dhr) review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, aes-50s, arthroscopic energy 50° probe with suction, 13 cm, was being used during a hip scope procedure on (b)(6) 2025 when it was reported, ¿during a hip arthroscopy, the tip of a conmed 50 degree rf wand became loose.It was swapped out for another 50 degree wand which was used to finish the case.Immediately after it was discovered by x-ray that the tip of the wand remained inside the patient.Following this procedure a ct scan will be used to evaluate whether the tip remains in the joint or if it is in soft tissue.¿.Further assessment questions found that the fragmentation was not retrieved the day of surgery but was removed the next day (b)(6) 2025) in a secondary surgery.This report is being raised due to the reported injury of secondary surgery required to remove component.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23153169
• Report Number: 1320894-2025-00231
• Device Sequence Number: 18680619
• Product Code: GEI
• UDI-Device Identifier: 30653405081917
• UDI-Public: (01)30653405081917(17)300514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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-50S
• Device Lot Number: 202505151
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic