MAUDE Adverse Event Report: ARTHROCARE CORPORATION REFLEX ULTRA PTR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC4835-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ent procedure, the reflex ultra coblator wand ceased working whilst within the turbinate, upon removal, tip of electrode was missing, metal tip appeared fractured.The procedure was successfully completed with a surgical delay greater than 30 minutes and the procedure was ceased to the point of failure.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: 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 alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual inspection performed observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is damaged, the electrode is pushed into the tip shaft.The cable of this device has been cut off.A functional evaluation was not performed due to the cut off cable the unit couldn't be tested.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.The root cause was associated with a component failure.Factors that could have contributed to the reported event include excessive force.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: REFLEX ULTRA PTR COBLATOR II
• 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: 21375824
• Report Number: 3006524618-2025-00055
• Device Sequence Number: 20988508
• Product Code: GEI
• UDI-Device Identifier: 00817470005455
• UDI-Public: 817470005455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202006
• 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
• Report Date (Section B): 03/24/2025

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 Expiration Date: 03/30/2025
• Device Catalogue Number: EIC4835-01
• Device Lot Number: 2116771
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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