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

Catalog Number	72290042
Medical Device Problem Code	Unintended Power Up (1162)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr procedure, the werewolf fastseal wand kept cutting off when the button was being pressed but it also continually run if it was held upside down without being pressed.The procedure was successfully completed with no delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a thr procedure, the werewolf fastseal wand kept cutting off when the button was being pressed but it also continually run if it was held upside down without being pressed.The procedure was successfully completed with no delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.

• Brand Name: WEREWOLF FASTSEAL 6.0
• 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: 13518121
• Report Number: 3006524618-2022-00056
• Device Sequence Number: 4207266
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: 885556787229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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: 11/05/2022
• Device Catalogue Number: 72290042
• Device Lot Number: 2082098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 11/24/2022
• Date Device Manufactured: 11/05/2021
• 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