MAUDE Adverse Event Report: ARTHROCARE CORP. TURBINATOR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EIC6895-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up for a turbinoplasty surgery, when the surgeon was priming the saline , the whole head of the turbinator coblator ii dropped out; it broke, the surgeon used an alternative rf to do the turbinoplasty as he had only one device with him.The procedure was successfully completed with no delay, changing the surgical technique.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 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.An analysis of the customer provided images found the head of the turbinator coblator ii detached and also the device identification pouch.The root cause of the reported event could not be determined since the device was not received for evaluation.Factors that could have contributed to the failure include rough handling or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: TURBINATOR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12580167
• Report Number: 3006524618-2021-00956
• Device Sequence Number: 19655483
• Product Code: GEI
• UDI-Device Identifier: 00817470000382
• UDI-Public: 00817470000382
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 02/20/2023
• Device Model Number: EIC6895-01
• Device Catalogue Number: EIC6895-01
• Device Lot Number: 2051295
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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: Male