MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF SRVC RF20000 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290105S
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the werewolf controller was not recognizing the wands.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A visual inspection of the controller shows a warranty seal which is in its original condition; it is not broken and untouched.During functional evaluation the controller was powered-up.The display shows the default settings as intended; a flow90 werewolf coblation wand was connected to the controller and the device did not recognize the wand as reported; an error occurred after pressing a foot pedal pad; a flow50 werewolf coblation wand was connected to the controller and this device was successfully recognized by the controller unit; the flow50 test wand produced plasma as specified; the unit was opened and found no issues.The complaint was confirmed and the root cause was determined to be a component failure without any design or manufacturing issue.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.No containment or corrective actions are recommended at this time.

• Brand Name: WEREWOLF SRVC RF20000 CONTROLLER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10681986
• Report Number: 3006524618-2020-00887
• Device Sequence Number: 14210057
• Product Code: GEI
• UDI-Device Identifier: 00885556645352
• UDI-Public: 00885556645352
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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 Model Number: 72290105S
• Device Catalogue Number: 72290105S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1