MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FLOW 50 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, a part of the electrode of the werewolf flow 50 coblation wand detached.The broken piece was removed, and patient was stable.The procedure was completed with 10 minutes of surgical delay using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.Bio debris is present.The electrode has been heavily used and partially eroded away.Product was out of the original packaging.No packaging returned.A functional evaluation revealed plugging the wand into the controller cause an end-of-life error.Using bypass software, the wand created plasma and coagulation with the available electrode pieces.The data extracted revealed the wand was activated previously and experienced a "check electrode on wand tip for excessive wear or clogging" error.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include device coming into contact with a metal object such as a cannula and mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

• Brand Name: WEREWOLF FLOW 50 COBLATION WAND
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17451552
• Report Number: 3006524618-2023-00298
• Device Sequence Number: 15322972
• Product Code: GEI
• UDI-Device Identifier: 00885556617472
• UDI-Public: 00885556617472
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K143235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 01/20/2025
• Device Catalogue Number: 72290037
• Device Lot Number: 2086499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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: Unknown