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

Model Number	72290105S
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Visual inspection observed no issues.Functional evaluation revealed the unit the does not turn on.The led's on the power supply do illuminate when plugged in. the complaint was verified and is associated with a component failure.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the identified malfunction, include a defective power supply or power entry module or a blown fuse.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.
Event or Problem Description
It was reported that the, before a shoulder procedure, the werewolf controller had a smoking smell coming from it.No patient involvement reported.Results of investigation revealed the unit the does not turn on which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 10976938
• Report Number: 3006524618-2020-01078
• Device Sequence Number: 3234906
• Product Code: GEI
• UDI-Device Identifier: 00885556645352
• UDI-Public: 00885556645352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1