MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FASTSEAL 6.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290042
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a hip procedure, the werewolf fastseal would turn on and not turn off.Surgery was completed with a back-up device instead.There was a surgical delay of less than 30 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference case: (b)(4).
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.The tip is worn from use, and product was out of the original packaging with no packaging returned.A functional evaluation was performed on the returned device and found that plugging in the wand causes a wand end of life error.Using a bypass box, the wand had no issues activating coag.The button did not get stuck nor did the device stay turned on.The button cover was removed and found no issues.Wand data shows the wand experienced a multiple button press warning.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.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.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: WEREWOLF FASTSEAL 6.0
• 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: 20096687
• Report Number: 3006524618-2024-00347
• Device Sequence Number: 15369898
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: 885556787229
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Catalogue Number: 72290042
• Device Lot Number: 2148268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2024
• 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