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

Model Number	AES-50SL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned used device, item aes-50sl found electrode tip detached from the device shaft.Also, distal back end of the shaft is badly damage (burned), due to the exposed return shaft being buried in tissue.However, the discoloration on the return shaft is most likely evidence of tissue.It appears that the electrode may have been buried in tissue, which reduced the surface area to less than that of the active electrode¿s surface area.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 21 complaints, regarding 24 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)(6).Per the instructions for use, the user is advised to maintain the probe tip, including the return electrode, in the field of view at all times.Injuries to the patient may result from inadvertent activation or movement of an activated probe outside the field of view.Care should be taken in procedures that may cover the probe return electrode.Alternate site ablation may occur if 75% of the return electrode is masked, making the return electrode surface area smaller than that of the active electrode.If partial coverage of the return electrode is required for the procedure, use a lower setting and maintain visibility of the return electrode while applying rf.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the aes-50sl was being used during a hip arthroscopy procedure on (b)(6) 2021 when it was reported ¿the internal component that holds the plate came out of the shaft¿.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning found that the component fell into the surgical site and was removed with a grasper.The patient was reported as ¿fine¿.This caused a few minutes delay; however, the procedure was completed as planned.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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
• MDR Report Key: 12548454
• Report Number: 1320894-2021-00369
• Device Sequence Number: 5555871
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)221114(10)202105181
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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 Expiration Date: 11/14/2022
• Device Model Number: AES-50SL
• Device Catalogue Number: AES-50SL
• Device Lot Number: 202105181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1