MAUDE Adverse Event Report: CONMED UTICA ARTHROSCOPIC ENERGY 90 DEGREE PROBE WITH SUCTION 18 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AES-90SL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the aes-90sl, arthroscopic energy 90 degree probe w suction 18 cm was being used during a hip labral debridement procedure on (b)(6)2023 date when it was reported ¿the tip of the aes-90sl broke when he was removing it from the joint and the edge of the tip caught on the cannula and ended up inside the patient.The broken piece was successfully removed causing no harm to the patient.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned and no photographic evidence has been provided therefore the reported event cannot 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 54 complaints, regarding 856 devices, for this device family and failure mode.(b)(4).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.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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the aes-90sl, arthroscopic energy 90 degree probe w suction 18 cm was being used during a hip labral debridement procedure on (b)(6) 2023 date when it was reported ¿the tip of the aes-90sl broke when he was removing it from the joint and the edge of the tip caught on the cannula and ended up inside the patient.The broken piece was successfully removed causing no harm to the patient.¿.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ARTHROSCOPIC ENERGY 90 DEGREE PROBE WITH SUCTION 18 CM
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17611120
• Report Number: 1320894-2023-00165
• Device Sequence Number: 20683306
• Product Code: GEI
• UDI-Device Identifier: 10653405004677
• UDI-Public: (01)10653405004677(17)240915(10)202303201
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 09/15/2024
• Device Catalogue Number: AES-90SL
• Device Lot Number: 202303201
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic