Description of Event or Problem · 1
ON 5/3/93 63 YEAR OLD IN FOR ELECTIVE TURP, LITHOTRIPSY. BLADDER STONE. PROCEDURE PROCEEDING WITHOUT COMPLICATIONS, WHEN LITHOTRIPSY MACHINE SUDDENLY STOPPED WORKING. ALL COMBINATIONS OF CORD ADJUSTMENTS WERE MADE WITHOUT SUCCESS. OTHER EQUIPMENT BEING USED DID NOT AFFECT THE FUNCTIONING OF THIS UNIT. PATIENT HAD TO RETURN TO THE OR ON 5/14/93 FOR COMPLICATION OF SURGERY. EQUIPMENT SENT TO BIO-MEDICAL ENGINEER FOR ASSESSMENT AND REPAIR.DEVICE NOT 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: OTHER. 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. RESULTS OF EVALUATION: COMPONENT FAILURE, ELECTRICAL PROBLEM, INVALID DATA. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.