MAUDE Adverse Event Report: CONMED 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	01/26/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the that the aes-50sl arthroscopic energy 50° probe with suction, xl, 18 cm, device was being used on (b)(6) 2026 during a hip arthroscopy procedure when it was reported ¿during the surgery, the tip detached and fell outside the patient, within the operative field.However, this was only noticed when the instrument was about to be reused.Immediate checks and a search were performed, as it was initially unclear whether the tip had detached inside or outside the patient.The tip was ultimately found outside the patient, within the operative field.¿.Further assessment found that the device did fragment and was removed from the surgical site.The procedure was completed with the use of the same alternate device and a 5-minute delay.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examinations of the returned used device, item aes-50sl, found electrode detached from the tip.Detached electrode was not returned for the evaluation.Examination was performed per edge probes.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be the use of 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.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 15 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 that if any visual damage or defects are noticed during use, stop using the device immediately and replace the device.Use care when inserting into and withdrawing the probe from a cannula or tissue portal to avoid the possibility of damage to the devices and/or injury to the patient.Do not insert, withdraw or touch the active tip of the probe when power is being applied.This may result in an unintended surgical effect, injury, or device damage.Do 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 customer reported that the that the aes-50sl arthroscopic energy 50° probe with suction, xl, 18 cm, device was being used on (b)(6) 2026 during a hip arthroscopy procedure when it was reported ¿during the surgery, the tip detached and fell outside the patient, within the operative field.However, this was only noticed when the instrument was about to be reused.Immediate checks and a search were performed, as it was initially unclear whether the tip had detached inside or outside the patient.The tip was ultimately found outside the patient, within the operative field.¿.Further assessment found that the device did fragment and was removed from the surgical site.The procedure was completed with the use of the same alternate device and a 5-minute delay.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.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; 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: 24237937
• Report Number: 1320894-2026-00023
• Device Sequence Number: 18387608
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)270314(10)202509151
• 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): 03/12/2026

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 Catalogue Number: AES-50SL
• Device Lot Number: 202509151
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2025
• 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
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic