D
Patient 1
WHILE POSITIONING TABLE IN REVERSE TRANDELENBERG CRANK WOULD NOT TURN AT SURGEONS INSISTENCE CRANK WAS FORCED CAUSING A NOISE AND THE TABLE TO JUMP. NURSE'S TOE WAS FRACTURED DURING THE INCIDENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.