MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF APL CONTROLLER (RF20000-APL); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290146
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a shoulder surgery, the werewolf controller will turn on automatically without a wand being pressed.The procedure was completed without delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H11.H3, h6.The reported device was received for evaluation.A visual inspection revealed a impact/drop damage.The screen bezel is cracked and the screen is slightly pushed in.The warranty seal is broken.A functional evaluation was performed on the returned device and found no issues.The device did not activate its functions on its own.The damage to the device did not prevent functionality.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 could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include a failure of a concomitant device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: WEREWOLF APL CONTROLLER (RF20000-APL)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13192705
• Report Number: 3006524618-2022-00012
• Device Sequence Number: 17607555
• Product Code: GEI
• UDI-Device Identifier: 00885556787236
• UDI-Public: 885556787236
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

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: 72290146
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 06/01/2023; 01/20/2026
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 06/05/2023; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown