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

Model Number	72290144
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup the controller was not turning all the way on.The light that normally glows green while powering on was instead glowing red.There was backup device available and no delay or complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned 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.A visual inspection observed a damaged bezel and the touchscreen is loose.Signs of impact damage around touch screen.A functional evaluation revealed the unit does boot up and the led checks pass on ports and saline pump, but the touchscreen is blank.The unit was opened and found the display cable is disconnected from the main board.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: 10624674
• Report Number: 3006524618-2020-00853
• Device Sequence Number: 16801961
• Product Code: GEI
• UDI-Device Identifier: 00885556739624
• UDI-Public: 00885556739624
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K192027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2020

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?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/04/2020
• Supplement Report FDA Received Date: 10/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1