Description of Event or Problem · 1
PATIENT UNDER GENERAL ANESTHESIA FOR INSERTION OF DOUBLE-J STENT INTO RIGHT URETER THROUGH CYSTOSCOPE, UNDER FLOUROSCOPY WITH VIDEO CAMERA. TABLE WOULD NOT MOVE SIDE TO SIDE OR UP AND DOWN, AND BUCKY WOULD NOT MOVE WHEN NEEDED. X-RAY DONE WHEN PATIENT WAS IN POST ANESTHESIA RECOVERY ROOM REVEALED PERFORATED RIGHT URETER. PATIENT WAS TAKEN BACK TO THE CYSTO ROOM AND STENT WAS REMOVED UNDER LOCAL ANESTHETIC. RIGHT NEPHROSTOMY TUBE WAS INSERTED UNDER I.V. ANESTHESIA IN RADIOLOGY DEPARTMENT. SCREW IN FOOT PEDAL WAS LOOSE, CAUSING MOTOR TO RUN CONTINUALLY, WHICH CAUSED CIRCUIT BREAKER TO TRIP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.