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

Model Number 72290144

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10624674
• MDR Text Key: 209779211
• Report Number: 3006524618-2020-00853
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556739624
• UDI-Public: 00885556739624
• Combination Product (y/n): N
• PMA/PMN Number: K192027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 72290144
• Device Catalogue Number: 72290144
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/04/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1