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

Catalog Number 72290038

Device Problem Self-Activation or Keying (1557)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an arthroscopy procedure, the werewolf flow 90 wand fired without activation via button or pedal.The procedure was completed with a delay of 1 to 2 minutes using a smith and nephew back-up device.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection revealed that two wands were received out of their original packaging, with no manufacturing abnormalities.Both had signs of use, but the second wand was more worn than the first one.No packaging returned.A functional evaluation was performed on the returned devices and found no issues with the first wand.No errors occurred.Plugging in the second wand caused a wand end of life error.Using bypass software, the wand was able to generate plasma as expected.Neither wand had issues with self-activation nor activating on their own.No errors occurred in testing of the second wand.Removing both wands button covers showed there was no saline ingress into the handle.Wand data is attached.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: 1) the wand´s connector or cable got damaged, 2) saline/humidity entered the interior of the handle shorting the connection of the buttons.No containment or corrective actions are recommended at this time.

Manufacturer Narrative

Investigation summary was updated: the reported device was received for evaluation.A visual inspection found the returned instrument shows no manufacturing abnormalities.The wand has signs of use.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found no issues.No errors occurred.Wand had no issues with self activation or activating on its own.Removing the wand's button cover showed there was no saline ingress into the handle.Wand data attached.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: 1) the wand´s connector or cable got damaged, 2) 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: 18290710
• MDR Text Key: 330042568
• Report Number: 3006524618-2023-00498
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2024

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: 2125148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/29/2024; Not provided
• Supplement Dates FDA Received: 03/04/2024; 06/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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