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

Catalog Number 72290134

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Feeding Problem (1850); Fistula (1862); Necrosis (1971)

Event Date 07/09/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during an excision of a mass of the cavum, necrosis of the soft palate occurred when using the coblation halo wand.According to the surgeon, the necrosis was related to the coagulant plate on the back of the electrode that burned the soft plate (nasal fase).Indeed, the triggering of a coagulation on the back of the wand (counter lateral electrode) when he pressed the "ablate" pedal.No delay was reported.A microdebrider competitor device was used to complete the procedure.This event has brought feeding difficulties, pain, velar incompetence and nasal reflux at each feeding, resulting in a nasopharyngeal fistula of several millimeters in diameter.A repair surgery will be scheduled when the lesions are stabilized.The lesion is evolving and an analgesic treatment is in place.

Manufacturer Narrative

Additional information in d4, h1 and h4.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.The customer provided image shows a side view of the electrode, spacer, shaft, and return shaft of the halo wand.The image does not provide any information related to the reported failure.The instructions for use was reviewed and found the electrode face or the exposed return can be used to provide a coagulation effect in coag mode, and that the exposed return should not contact non-targeted tissue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Since this event is has not been resolved, the future impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint would be re-assessed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: COBLATION HALO WAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12291706
• MDR Text Key: 265560455
• Report Number: 3006524618-2021-00816
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K192027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72290134
• Device Lot Number: 2060077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 08/09/2021; 10/07/2021
• Supplement Dates FDA Received: 08/10/2021; 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: A REPAIR SURGERY WILL BE SCHEDULED WHEN THE LESION
• Patient Outcome(s): Required Intervention
• Patient Age: 4 MO