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

Model Number	AES-50SL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.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 35 complaints, regarding 38 devices, for this device family and failure mode.During this same time frame 170,303 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 0.0002.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.The ifu also advises the user 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.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.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 "account # (number) had an issue with aes-50sl, lot 202103161.The metal plate completely broke off when using.This is not the first time they've had this issue with our edge probes." the procedure was completed after a 5-minute delay with no report of injury, medical intervention, or hospitalization for the patient.All components were retrieved from the patient.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 CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11967403
• Report Number: 1320894-2021-00274
• Device Sequence Number: 4308767
• Product Code: GEI
• UDI-Device Identifier: 10653405004974
• UDI-Public: (01)10653405004974(17)220912(10)202103161
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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 Model Number: AES-50SL
• Device Catalogue Number: AES-50SL
• Device Lot Number: 202103161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1