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

Catalog Number 72290038

Device Problem Activation Failure (3270)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a shoulder rc, the werewolf wand did not respond.The procedure was successfully completed with a surgical delay greater than 30 minutes using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.An analysis of the customer provided images found the wand on the surgeon's hand, connected to the werewolf coblation system.The wand is registering on the controller, but it can't be seen if the wand responded or not.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Bio debris is present.No other visual issues were observed.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found that plugging the wand into the controller cause an end-of-life error.Using bypass software, the wand created plasma and coagulation as intended.The data extracted revealed the wand was activated previously and experienced a "multiple button pressed notification".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 could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include a short in the wand because of the saline ingress.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: 18229923
• MDR Text Key: 330457672
• Report Number: 3006524618-2023-00479
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 05/20/2024

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 Catalogue Number: 72290038
• Device Lot Number: 2112153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/08/2024; 05/16/2024
• Supplement Dates FDA Received: 01/11/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female