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

Model Number 72290038

Device Problem Failure to Shut Off (2939)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy procedure with the werewolf wand, the controller's screen displayed "multiple buttons or foot controls have been pressed simultaneously" while pressing the ablation button.The wand did not stop to ablate when the button was released.The issue was resolved by disconnecting the wand.The procedure was completed without surgical delay using a back up device.No further complications were reported.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection revealed the instrument shows no manufacturing abnormalities.The tip is heavily worn from use.The connector pins are damaged and have minor corrosion on them.Product was out of the original packaging and no packaging returned.A functional evaluation was performed on the returned device and found a wand end of life error when plugged into a controller.Using bypass software the wand had no issues producing plasma or activating.The wand never had a multiple button press error occur in testing.Removing the button covers found heavy saline ingress on the button boards.Wand data shows the device experienced a multiple button press error.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 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.The root cause for the wand not stopping to ablate when the button was released, was not determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.The root cause for the "multiple buttons have been pressed simultaneously" error message has been associated with unintended use of the device.Factors that could have contributed to the failure include the wand´s connector or cable got damaged, 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: 15961046
• MDR Text Key: 305366566
• Report Number: 3006524618-2022-00506
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: 2094159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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