[45]
67 year old male, being treated in icu for multiple medical problems including a life-threatening and uncontrollable, tracheal hemorrhage fromerosion. On 12/10/91 the patient was taken to the or for a rigid bronchoscopy with laser. The et tube that was in place was changed due to blood clots and a #9 pvc tube placed. The procedure was then changed to a fiberoptic bronchoscopy with yag laser. The fiberoptic bronchoscopy was positioned approximately 1 cm distal to the et tube and the yag laser was situated 1cm distal to the tip of the fiberoptic bronchoscope. Wattage was set at 30, power set at 30 watts with one second pulses. After four or five doses of yag laser coagulation therapy, the tip of the et tube ignited and a tracheal fire occurred. Patient suffered thermal burns of the trachea, left mainstem bronchus, left upper lobe bronchus, and left lower lobe bronchus. This patient was critically ill and it was necessary during the procedure to deliver 100% oxygen. Patient expired 12/19/91 @ 1447device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: manufacturer. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: electrical tests performed, performance tests performed. Results of evaluation: end of life - expected, other, patient's condition - predisposed event. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by other facility staff, invalid data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5