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

Catalog Number	72290134
Medical Device Problem Codes	Peeled/Delaminated (1454); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that after an adenoidectomy procedure, the patient lip was burnt on the corner where the coblation halo wand has been laying on the lip.The wand was inspected, it appears as the casing have been compromised and the metal underneath seems to have blanched the patient¿s lip.The burn on the lip was white and 1st degree, vaseline was applied on the burn.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).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.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 the limited information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device ifu does warn, ¿do not use the product if it is damaged or if the product is not fully functioning¿.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
H6 codes updated.Results of investigation: the reported device was received for evaluation.A visual inspection observed the returned instrument shows no manufacturing abnormalities.The saline line has been cut from the end of the device, but most of the line remains.The shaft sleeve has been damaged from an external object, exposing internal shaft metals halfway up the shaft.Product was out of the original packaging.No packaging returned.A functional evaluation revealed plugging in the wand causes 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 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.A clinical review states that based on the limited information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The device instructions for use does warn, ¿do not use the product if it is damaged or if the product is not fully functioning¿.The root cause has been associated with component failure.Factors that could have contributed to the reported event include damaged insulation from contact with another surface (i.E.Metal mouth gag).Based on this investigation, the need for corrective action is not indicated.

• 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: 19951474
• Report Number: 3006524618-2024-00315
• Device Sequence Number: 8802134
• Product Code: GEI
• UDI-Device Identifier: 00885556699928
• UDI-Public: 00885556699928
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

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: 2152908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 12/23/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/20/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2024
• 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