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

Model Number 72290038

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a coblation procedure using the werewolf coblation wand, the patient responded with signs of electrocution when surgeon was using both the ablation and coagulation mode.The procedure was completed with a non-significant delay using a back-up device.No further complications were reported.

Manufacturer Narrative

H10 h3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned instrument shows no manufacturing abnormalities.The tip is worn from use and the shaft near the tip is shrunk from excessive heat or melting.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found that the opened device was tested and plugged into the controller and caused a wand expired error.Using a bypass box the device had no issues producing plasma on the ablation settings.When activating the coag settings after a short duration the unit displays wand short circuit error, please replace wand.No sparking or arcing is seen when the device is in use.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states that based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.The root cause of the events has been associated with a component failure.Factors that could have contributed to the electrical shorting include moisture in the connection causing a wand short or incomplete connection.Factors that could have contributed to the material deformation include mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue, contact of the tip and/or shaft insulation with metal objects while activating the wand.Contacting the distal portion of cannula with the shaft when inserting and removing the wand.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: 14408169
• MDR Text Key: 291727638
• Report Number: 3006524618-2022-00238
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556647462
• UDI-Public: 00885556647462
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K183346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72290038
• Device Catalogue Number: 72290038
• Device Lot Number: 2087988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Male