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

Catalog Number	72290146
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during a bilateral myringotomy with adenoidectomy, the werewolf controller had a defect in the sheath and the patient suffered a superficial mucosal abrasion.The patient was treated with bacitracin in the or suite.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H11: corrected information in b5.
Event or Problem Description
It was reported that during a bilateral myringotomy with adenoidectomy, the werewolf controller had a defect in the sheath and the patient suffered a superficial mucosal abrasion.The patient was treated with bacitracin in the or suite.The procedure was completed with a s+n back up device.There was a delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the lid is cracked, and no arc/burn damage on the device.There is no type of sheath on a werewolf controller.A functional evaluation was performed on the returned device and found no issues.The unit had proper output voltage and did not show any signs of overheating/sparking.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 no similar reported events.The instructions for use were 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 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.A clinical review states a controller and a wand were returned for evaluation and results note that the coblation wand had shaft damaged from heavy tool markings.An area of the shaft was ripped off exposing the internal metal, the device was not melted; and the damaged was from a tool or other object.There is a definitive clinical root cause.Based solely on the results of the product evaluation from the wand the root cause of the reported issue was the result of a user technique vs procedural variance.It was noted that the device was not melted, and the damage is from heavy tool markings.The patient impact is determined to be the reported first-degree burn on the inside of the mouth/ lip and the 30-minute surgical extension.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include damage from heavy tool markings.Based on this investigation, the need for corrective action is not indicated.

• 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: 19927738
• Report Number: 3006524618-2024-00306
• Device Sequence Number: 2847386
• Product Code: GEI
• UDI-Device Identifier: 00885556787236
• UDI-Public: 00885556787236
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2024

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 Catalogue Number: 72290146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/03/2024; 09/05/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/03/2024; 09/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown