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

Model Number	72290105S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that werewolf controller's power button came apart from console and pushed inside the machine, during set up or inspection for an unknown procedure.The procedure was completed with a competitor's device.No patient injury or delays were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3,h6: 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.Review of the product ifu found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.Please refer to the instructions for use for recommendations on the controller has no operator-serviceable parts.It is designed to provide consistent output levels and is calibrated by clock crystals, voltage references, and fixed resistors.There are no internal adjustments in the instrument and no annual maintenance check is required.If a component malfunctions, call customer service for a return authorization.A visual inspection observed the warranty seal is broken and the power button is pushed inside the unit.A functional evaluation revealed the unit cannot be tested due to the power button being pushed inside the unit.The unit was opened and found multiple cables disconnected from the main board.The complaint was verified.Factors that could have contributed to the reported event include rough handling or excessive force when trying to actuate the power button.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: 11018756
• Report Number: 3006524618-2020-01095
• Device Sequence Number: 14116422
• Product Code: GEI
• UDI-Device Identifier: 00885556645352
• UDI-Public: 00885556645352
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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?: 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: 12/23/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/04/2021
• 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: Other; Required Intervention