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

Catalog Number	72290134
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Burn(s) (1757); Localized Skin Lesion (4542)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a tonsillectomy/ adenoids surgery that had been performed on (b)(6) 2025, the patient experienced a lesion near the mouth and when looking at the wand, there was a noticeable flaw along the shaft that could have come into contact with patient.The patient as of now is ok, just a lesion right outside of the mouth.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Corrected data: b5, h6 (health effect - clinical code).
Event or Problem Description
It was reported that after a tonsillectomy/ adenoids surgery that had been performed on (b)(6) 2025, the patient experienced a burn on the outer cheek and when looking at the wand, there was a noticeable flaw along the shaft that could have come into contact with patient.The patient as of now is ok, just the burn right outside of the mouth.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is worn from use.The shaft covering near the tip is pulled back, exposing some of the metal shaft below it.A functional evaluation was performed on the returned device and found 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 specification 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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (unintended impact event inconsistent with normal use).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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23700864
• Report Number: 3006524618-2025-00685
• Device Sequence Number: 18801847
• Product Code: GEI
• UDI-Device Identifier: 00885556699928
• UDI-Public: 885556699928
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: 2181924
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/08/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2025
• 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