MAUDE Adverse Event Report: ARTHROCARE CORP. 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 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported, during a procedure, while using a werewolf coblation wand, the "ablate" function could not be stopped.Surgery was resumed, after a non-significant delay, with a back-up device.No patient complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.Product was out of the original packaging.No packaging returned.The data extracted revealed the wand was activated previously and experienced a "multiple button pressed notification" error.Device was tested, and generated plasma and coagulation as intended.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: 1)the wand´s connector or cable got damaged.2) saline/humidity entered the interior of the handle shorting the connection of the buttons.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.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 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: 13938773
• MDR Text Key: 288106991
• Report Number: 3006524618-2022-00116
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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: 2083173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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