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.
|
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.
|