MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF FLOW 90 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 72290038

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Event Description

It was reported that, during a hip arthroscopy, internal to the patient, the wand's insulation started to shred off approximately 3 cm from the tip.The in-joint temperature was measured to 63 degrees celsius.The procedure was completed without delay using a back-up 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.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.There was a relationship found between the device and the reported incident, as an image of the device was submitted by the customer.A review of the device history records for the device showed there were 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.Visual analysis of the submitted photo revealed damage to the insulation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed as the submitted image provided sufficient evidence to confirm the complaint.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1) pressing the tip against hard or bony surfaces.No containment or corrective actions are recommended at this time.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: WEREWOLF FLOW 90 COBLATION WAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11069173
• MDR Text Key: 223608979
• Report Number: 3006524618-2020-01144
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• PMA/PMN Number: K183346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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 Expiration Date: 01/21/2022
• Device Model Number: 72290038
• Device Catalogue Number: 72290038
• Device Lot Number: 2048944
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1