MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF ENT 8-PIN ADAPTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290136
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a turbinate reduction procedure, the adapter of the werewolf ent started smoking and burned.It is not known if the problem is the adaptor or the console.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection observed the center pin of the 8pin adapter has arc/burn damage to it.A functional evaluation revealed due to the condition of the returned device, it was not tested further.The complaint was confirmed and the root cause was associated with a component failure.Factors, which could have contributed to the complaint event, include there may be a damaged receptacle, plugging in a wet wand connector, or exposure of saline to the wand receptacle of the adapter.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 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.No containment or corrective actions are recommended at this time.

• Brand Name: WEREWOLF ENT 8-PIN ADAPTER
• 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: 14682223
• Report Number: 3006524618-2022-00292
• Device Sequence Number: 20104791
• Product Code: GEI
• UDI-Device Identifier: 00885556699942
• UDI-Public: 00885556699942
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 72290136
• Device Catalogue Number: 72290136
• Device Lot Number: 2065927
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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