[504]
Patient was admitted at 7:00 am, july 21, 1991, for same day surgery for diagnostic hysteroscopy/laparoscopy. Admitting diagnosis was uterine fibroids. Pateint was anesthesized and was prepared for the procedure. The surgeon put hysterscope into the uterus and stated he was not getting enough fluid. The scope was removed from the patient, and the pressure was increased. The surgeon was still not receiving enough fluid. The tubing was re-primed. The usual "pressure noise" was heard and the fluid was flowing at a normal rate. The scope was reinserted into the patient, and good visualization was obtained. At this time, the patient became asystole and cyanotic. Cpr was initiated immediately, chest tubes inserted and the abdomen was open. All attempts to resusiciate the patient was futile. Autospy performed. Report not yet available. The manufacturer was notified and an intense investigation was commenced and is still in progressdevice 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. Invalid data - regarding whether event presents imminent hazard. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, a device from same lot was evaluated, other, other. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: maybe. Corrective actions: none or unknown. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5