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

Model Number 72290134

Device Problem Material Deformation (2976)

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

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported that, during set up, at the moment of bending two (2) coblation halo wands with the evac bending tool, the electrode came apart, the electrode tip loosen and kinked saline line on the wand.There was a back-up device available and no delay was reported.There was no patient involvement.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10 h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The tip of both wands are heavily worn.The tips are separated and the electrodes are flared outward from an external object.The tips were bent after they were used from the use markings.Product was out of the original packaging.No packaging returned.Functional evaluation revealed the wands were not tested for plasma production due to their tip damage.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 unintended use of the device.Factors that could have contributed to the failure include excessive force to the device, mechanical displacement of tissue through applied force, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: COBLATION HALO 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: 15157370
• MDR Text Key: 297230179
• Report Number: 3006524618-2022-00338
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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 Expiration Date: 06/01/2023
• Device Model Number: 72290134
• Device Catalogue Number: 72290134
• Device Lot Number: 2055223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 05/27/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• 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