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

Model Number	72290105
Medical Device Problem Codes	Protective Measures Problem (3015); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during the set up before the surgery the werewolf starting to make a loud noise, there is also an error reported when the device is being used.No delay or other complications reported.Change in surgical technique was required in order to complete the surgery.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.The instructions for use was reviewed, and found to include conditions of off label use.And technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files, found that the reported failure was documented appropriately.Visual inspection observed no issues.Functional evaluation revealed, the unit on power up and after reaching the initial splash screen, the screen goes blank and the alarm tone is heard.The unit was opened and found no issues.The complaint was confirmed, and the root cause is associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device, which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.

• 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: 11663400
• Report Number: 3006524618-2021-00473
• Device Sequence Number: 3127944
• Product Code: GEI
• UDI-Device Identifier: 00885556624890
• UDI-Public: 00885556624890
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/01/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention