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

Catalog Number	EIC4845-01
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the most anterior tip of the reflex ultra coblator ii broke in the patient's tissue.All pieces were removed from the patient's tissue.The procedure was completed without delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The electrode has been used.Bio debris is present.The tip is not jagged, as from a break, but is worn smooth, and is level with the edge of the tube.The device was returned in original packaging with the batch number of the complaint on the label.A functional evaluation showed the opened device was tested and plugged into the controller and registered settings (4,2).The wand produced plasma and coagulation from the tip, as expected.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) using the device as a lever to enlarge surgical site.(2) mechanical displacement of tissue through applied force.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: 17770002
• Report Number: 3006524618-2023-00360
• Device Sequence Number: 15112670
• Product Code: GEI
• UDI-Device Identifier: 00817470004212
• UDI-Public: 00817470004212
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/22/2024

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: 01/20/2026
• Device Catalogue Number: EIC4845-01
• Device Lot Number: 2112045
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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