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

Catalog Number 72290134

Device Problem Material Deformation (2976)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during an adenotonsillotomy, the coblation halo wand had an insulation defect that caused a second degree burn to the mucosa on the right inner lip.The procedure was completed with a non-significant delay using the same device.No further complications were reported.

Manufacturer Narrative

H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 the provided undated photos confirm the reported burn to the patient with blistering indicating a second-degree burn.Photos of the device were also provided for review, in which part of the insulation appears to be missing.Based on the limited information provided we are currently unable to rule out a procedural variance or technique related issue as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu_96423_b does note that ¿the system should be inspected prior to, and periodically during surgery for any damage, as this could adversely impact performance, safety, and clinical outcome.Do not use if damaged or malfunctioning¿ and that the ¿suction line should not contact patient as it may cause a burn.¿ the patient impact beyond the reported burn injury 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.

Manufacturer Narrative

H10 h3,h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The cables of the device have been cut off.The tip is worn from use.The shaft insulation has been hit with an external object, there is damage along the shaft in multiple locations from continually hitting an external object and at the center of the damage the insulation has been pushed to one side, exposing the internal shaft.The exposed shaft is darkened in color.The device cannot be tested due to the removed cables.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 the provided undated photos confirm the reported burn to the patient with blistering indicating a second-degree burn.Photos of the device were also provided for review, in which part of the insulation appears to be missing.Based on the limited information provided we are currently unable to rule out a procedural variance or technique related issue as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu_96423_b does note that ¿the system should be inspected prior to, and periodically during surgery for any damage, as this could adversely impact performance, safety, and clinical outcome.Do not use if damaged or malfunctioning¿ and that the ¿suction line should not contact patient as it may cause a burn.¿ the patient impact beyond the reported burn injury could not be determined.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, 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 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: 17812762
• MDR Text Key: 324189238
• Report Number: 3006524618-2023-00370
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556699928
• UDI-Public: 00885556699928
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192027
• 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,Followup
• Report Date: 02/26/2024

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: 2122312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 11/07/2023; 12/06/2023
• Supplement Dates FDA Received: 11/09/2023; 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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
• Patient Outcome(s): Other