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

Catalog Number 72290038

Device Problems Device Alarm System (1012); Melted (1385)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff surgery, the werewolf flow 90 coblation wand alarm for the temperature alert sounded repeated despite minimal activation; even when removed from the patient, the wand continued to sound its alarm as well.It was also noted that the plastic along the shaft of the wand seemed melted.The procedure was completed using a s+n back up device.There was a delay of less than 30 minutes.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint reference case-(b)(4).The reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Bio debris is present.The distal end of the black wand wrap is deformed.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, but both caused a temperature spike and alarm when activated.No other error message was given.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 has been associated with a component failure.Factors that could have contributed to the failure include not sufficient suction pressure in order to ensure adequate flow and circulation of saline solution to prevent unnecessary heating which could have caused the temperature to elevate, or the user may not have set the controller temperature threshold to the desired value.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: 18819189
• MDR Text Key: 336864334
• Report Number: 3006524618-2024-00088
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 2134174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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