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

Model Number 72290038

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during a shoulder arthroscopy two(2) werewolf flow 90s stopped working.The procedure was completed with a surgical delay greater than 30 minutes using a back up device.No further complications were reported.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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 found 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.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were found.Product was out of the original packaging.No packaging returned.The opened device was tested and plugged into the controller and the controller displayed ¿wand has reached end of life¿ error.A bypass box was used with the wand and no issues occurred.The wand data was reviewed and the customer experienced a multiple button press error.The complaint was confirmed and root cause associated with unintended use of the device.Factors that could have contributed to the reported event include: the wand´s connector or cable got damaged and/ or shorting the connection of the buttons or saline/humidity entered the interior of the handle shorting the connection of the buttons.No containment or corrective actions are recommended at this time.

• Brand Name: WEREWOLF FLOW 90 COBLATION WAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16138727
• MDR Text Key: 307896653
• Report Number: 3006524618-2023-00035
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K183346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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: 72290038
• Device Catalogue Number: 72290038
• Device Lot Number: 2098678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/11/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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