MAUDE Adverse Event Report: ARTHROCARE CORPORATION COBLATOR II CONTROLLER (240V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	13546-02
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during an ent procedure, the coblator ii caught fire, there was a lot of smoke.The procedure was completed using a smith and nephew back up device in another operating room.It is unknown if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.Visual inspection of the returned device show a broken warranty void.The unit have been previously opened.The manufacturing date is 2023-06-26; no manufacturing anomalies were found.The top cover of the unit was opened.There were different internal damaged components visually found.A bloated electrolytic capacitor, a burnt transformer [t3) which shows an abnormal discoloration, indicating overheating and a broken off coil.The mainboard is defect.A functional evaluation was not possible cause of the burnt mainboard.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 electrical component failure.Factors that could have contributed to the failure include a power surge in the controller or a failure of an internal component.No containment or corrective actions are recommended at this time.

• Brand Name: COBLATOR II CONTROLLER (240V)
• 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: 18047343
• Report Number: 3006524618-2023-00414
• Device Sequence Number: 7500411
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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 Catalogue Number: 13546-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown