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

Model Number	72290144
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up or inspection when turned on the werewolf ent, no power goes to the screen.No surgical delay.The procedure was completed with a smith and nephew back up of different technology(procise max).Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6 the reported device, intended for use in treatment, was received for evaluation.There was a 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 an isolated event.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.Visual inspection observed no issues.The warranty seal was not broken.Functional evaluation revealed the unit does not power up, but the power supply led's do illuminate when plugged in.Additional evaluation on opening the unit revealed the power supply control cable was loose, not fully plugged into j40 connector.Fully seating this cable resolved the power issue.The complaint was confirmed and is associated with a component failure.Factors, unrelated to the manufacturing and design of the device, which could have contributed to the reported event, include consistent heavy movement of the device causing internal wires to come loose.

• 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: 11725394
• Report Number: 3006524618-2021-00513
• Device Sequence Number: 3647144
• Product Code: GEI
• UDI-Device Identifier: 00885556739624
• UDI-Public: 00885556739624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Model Number: 72290144
• Device Catalogue Number: 72290144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other