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

Catalog Number	72290146
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, a werewolf controller was not working.Surgery was resumed, without any delay, with a back-up device.No patient complications were reported.During investigation it was found that the device had smoke coming from the power supply fans area.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection observed dried fluid on the power plug and power supply fans area.A functional evaluation revealed the unit tripped the breaker for my workstation and had smoke coming from the power supply fans area.The unit was opened and found dried liquid around the power supply fans area.The unit was not tested further due to potential equipment damage.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 found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed and 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.

• Brand Name: WEREWOLF APL CONTROLLER (RF20000-APL)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14678270
• Report Number: 3006524618-2022-00285
• Device Sequence Number: 5410520
• Product Code: GEI
• UDI-Device Identifier: 00885556787236
• UDI-Public: 885556787236
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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 Catalogue Number: 72290146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/13/2023
• 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