MAUDE Adverse Event Report: ARTHROCARE CORP. WEREWOLF FASTSEAL 6.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 72290042

Device Problems Smoking (1585); Failure to Shut Off (2939)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an tha surgery, the doctor was using a fastseal inside the joint and when he stopped pressing the button the device was still going, spewing fluid and smoke for 45 seconds outside the joint before stopping on its own.The procedure was successfully completed with non-significant delay using a competitor device.No further complications were reported.

Manufacturer Narrative

H10: h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was no relationship found between the device and the reported event.The complaint was not confirmed.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: WEREWOLF FASTSEAL 6.0
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15755022
• MDR Text Key: 303324331
• Report Number: 3006524618-2022-00473
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: 00885556787229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: 72290042
• Device Catalogue Number: 72290042
• Device Lot Number: 2098013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2023
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1