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

Model Number	72290144
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during t&a the werewolf ent was not working; 3 halo wands were connected to the unit and saline would flow out of the wand but it would not ablate or coagulate.A wand was tested in a bowl of saline and no plasma seemed to be forming (no orange glow either), two more wands were tried without success.Then, the werewolf generator was replaced with another werewolf ent unit and the new halo wands opened worked as expected.The procedure was completed without delay using a s+n backup device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h2, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection observed no issues.Functional evaluation revealed revealed the flow 50 wand has no output voltage.The unit was opened and found no issues.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.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.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• Brand Name: WEREWOLF ENT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10356774
• Report Number: 3006524618-2020-00566
• Device Sequence Number: 14107836
• Product Code: GEI
• UDI-Device Identifier: 00885556739624
• UDI-Public: 00885556739624
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 72290144
• Device Catalogue Number: 72290144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1