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

Model Number	72290105
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a knee arthroscopy, meniscal stitch, an error appeared: "the electrode is expired.Replace electrode".The electrode was new, not expired.Another electrode was opened, the error persisted.When the generator is turned on, the windows are now lit in red, which should be blinking green.There is an error message on the screen.They turned on and off the generator, disconnected from the network, the error did not disappear.The surgeon completed the procedure without any ablator (he used shaver during the operation).There was a delay of less than or equal to 30 min.No other complications were reported.
Additional Manufacturer Narrative
H10 h6 the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.Visual inspection of the customer provided pictures shows the 18pin port having its red error led illuminated with nothing plugged into it, and in a second picture an error code is displayed on the screen.There was a relationship found between the subject 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.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: 11800974
• Report Number: 3006524618-2021-00592
• Device Sequence Number: 17059057
• Product Code: GEI
• UDI-Device Identifier: 00885556624890
• UDI-Public: 00885556624890
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K162074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 72290105
• Device Catalogue Number: 72290105
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/03/2021
• 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