MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FLOW 90 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290038
Medical Device Problem Codes	Corroded (1131); Self-Activation or Keying (1557); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that 20 minutes after an acromioplasty the werewolf was making the coag sound even though the wand was not activated, and the touch screen was showing that coag function was being activated.The back button was pressed to stop the wand but then when the doctor wanted to use the coblation (yellow button) the machine error-messaged that 2 buttons were being pressed simultaneously.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is worn from use.Functional evaluation revealed plugging in the wand causes a wand end of life error.Using a bypass box, the wand had no issues producing plasma.The wands coag button does not function when pressed.Coag will activate via foot pedal.Removing the button covers reveals heavy saline ingress on the button boards.Corrosion and heavy dried liquid covers the board.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 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.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factors include saline/humidity entering the interior of the handle shorting the connection of the buttons.Based on this investigation, there is no evidence to suggest a design, material, or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: WEREWOLF FLOW 90 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: 20797483
• Report Number: 3006524618-2024-00509
• Device Sequence Number: 15401536
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 885556647462
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K183346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 72290038
• Device Lot Number: 2155609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2024
• 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