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

Model Number	EC8001-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during set up of a intracapsular tonsillectomy procedure; before the patient was anesthetized; while plugging the coblator ii system, it had a burnt smell and smoke that came out from the generator.The procedure was cancelled and no further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on a2 and a3.
Additional Manufacturer Narrative
H3, h6: a device deficiency was identified.However, the root cause of the reported event could not be determined since the device was not returned for evaluation.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.An analysis of the customer provided image found the coblator ii controller laying in a cart system between two other devices, multiple chords can be seen in the image, as well as a foot pedal.There is visible smoke in the image.However, it was not possible to confirm the source of the smoke.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 15974396
• Report Number: 3006524618-2022-00507
• Device Sequence Number: 17873186
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: EC8001-01
• Device Catalogue Number: 13546-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 06/06/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/30/2022; 06/07/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Male