MAUDE Adverse Event Report: ARTHROCARE CORPORATION REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC4845-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an ent procedure, the tip of the reflex ultra coblator wand was not found.The doctor was not sure if the tip was inside the patient or melted.The procedure was finished with the same faulty device.There was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided image was performed and found the device on top of the package with the needle bent.Another image showed the device next to another one demonstrating that the tip was missing.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 no 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 unintended use of the device.Factors that could have contributed to the reported event include 1) hitting the device tip against a hard surface.2) using the device as a lever to enlarge surgical site.3) mechanical displacement of tissue through applied force.4) activating the device above recommended settings for prolonged periods of time, thus causing the electrode to become eroded extensively.No containment or corrective actions are recommended at this time.

• Brand Name: REFLEX ULTRA 45 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: 18896037
• Report Number: 3006524618-2024-00093
• Device Sequence Number: 15374265
• Product Code: GEI
• UDI-Device Identifier: 00817470004212
• UDI-Public: 00817470004212
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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 Expiration Date: 07/20/2026
• Device Catalogue Number: EIC4845-01
• Device Lot Number: 2121390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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