MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF RF 20000 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290105
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(6).
Event or Problem Description
It was reported that during a rotator procedure, the werewolf rf 20000 controller made a loud noise, blew up sparks out of the rear of the machine where the fan is, and powered off.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was no 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 observed the warranty seal is broken.A functional evaluation revealed no issues.The unit was opened and found no burn marks or signs of sparks.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• Brand Name: WEREWOLF RF 20000 CONTROLLER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12443819
• Report Number: 3006524618-2021-00902
• Device Sequence Number: 19660214
• Product Code: GEI
• UDI-Device Identifier: 00885556624890
• UDI-Public: 00885556624890
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 72290105
• Device Catalogue Number: 72290105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2021
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1