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

Catalog Number	72290134
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Codes	Burn(s) (1757); Superficial (First Degree) Burn (2685)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a bilateral myringotomy with adenoidectomy procedure, the black shaft of the coblation halo wand melted and burned the inside of the patient's mouth and lip, causing a superficial mucosal abrasion that was treated with bacitracin in the or suite.The wand was activated for approximately 10 minutes and the lip was not protected for the procedure.The procedure was completed using a smith and nephew back up device.There was a delay greater than 30 minutes and no further complications were reported.The patient was discharged home the same day.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.The shaft is damaged from heavy tool markings.An area of the shaft is ripped off exposing the internal metal.It is not melted; it is damaged off from a tool or other object.There are no burn/arc marks on the shaft.The tip is worn from use.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the returned device and found a wand end of life error.Using a bypass box, the wand had no issues producing plasma or activating coag.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 no 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 solely on the results of the product evaluation the root cause of the reported issue was the result of a user technique vs procedural variance.It was noted that the device was not melted, and the damage is from heavy tool markings.The device ifu does warn, ¿do not use the product if it is damaged or if the product is not fully functioning¿ and ¿care should be taken in monitoring the targeted tissue during ablation to ensure consistent and controlled tissue removal is maintained.Care should also be taken to ensure surrounding tissue is properly monitored.¿ the patient impact is determined to be the reported first-degree burn on the inside of the mouth/ lip.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include damage from heavy tools markings.Based on this investigation, the need for corrective action is not indicated.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: COBLATION HALO WAND
• Common Device Name: 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: 19913311
• Report Number: 3006524618-2024-00299
• Device Sequence Number: 15540108
• Product Code: GEI
• UDI-Device Identifier: 00885556699928
• UDI-Public: 00885556699928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72290134
• Device Lot Number: 2151139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown