[490]
During laser removal of the gallbladder the saphire tip and screw assembly seperated from the optical fiber. The attached saphire tip fell into the space formally occupied by the gall bladder, the doctor took prompt action and located the tip assembly and recovered the assembly from the patient. The physician then carefully examined the area for any signs of tissue damage. No injury was found. The examination was completed using the high defination television camera and checks of the area revealed no signs of burns due to the flow of event during the procedure. No outstanding difficulties were encountered. This fiber will be examined by our slt representative as to possible cause and/or quality control improvements. The insertation tool will be examined by the manufacturer as to the condition internal guide and control tensions on the instrumentdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination, other. Results of evaluation: component failure, telemetry failure, none or unknown, none or unknown. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor, user education provided, inserviced by biomedical engineering dept. Staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5