MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF APL CONTROLLER (RF20000-APL); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290146
Medical Device Problem Codes	Smoking (1585); Sparking (2595); Communication or Transmission Problem (2896); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up, the werewolf controller monitor does not respond to machine being turned on.A loud pop was heard with initial power-on of the day, followed by smoke plume; the device did spark and the smell of hot electricity was acknowledged.A back up device was available to complete the procedure.There was no delay and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.Visual inspection observed a damaged lid and bezel.The warranty seal was intact.Functional evaluation revealed the unit does not power on when the power button is pressed.The led's on the power supply do illuminate when plugged in and react to the power button being pressed.The unit was opened and found dried liquid under the power supply and signs that the liquid has touched wires on the back side, but no burn or arc damage was found.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with a failure to follow instructions.Factors, which could have contributed to the complaint event, include exposure of saline or a liquid to the power plug or power supply intake.No containment or corrective actions are recommended at this time.H11: h2: correction on b3, b5 and h6 (medical device problem code).
Event or Problem Description
It was reported that during set up, the werewolf controller monitor does not respond to machine being turned on.A loud pop was heard with initial power-on of the day, followed by smoke plume; the device did spark and the smell of hot electricity was acknowledged.A back up device was available and there was no delay.There was no patient involvement.

• Brand Name: WEREWOLF APL CONTROLLER (RF20000-APL)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16503096
• Report Number: 3006524618-2023-00080
• Device Sequence Number: 15012653
• Product Code: GEI
• UDI-Device Identifier: 00885556787236
• UDI-Public: 00885556787236
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 72290146
• Device Catalogue Number: 72290146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown