Description of Event or Problem · 1
THE LASER INDIRECT OPHTHALMOSCOPE WAS USED WITH THE ARGON GREEN WAVE LENGTH. WITH A 50 MICRON SPOT SIZE, A 100 MSEC DURATION WAS USED. THE INTENSITY RANGED FROM 1.0 TO 1.8 WATTS, MEASURED PRIOR TO FILTERING OUT THE BLUE WAVE LENGTH. TREATMENT WAS PLACED FOCALLY TO ALL MICROANEURYSMS, SPARING THE CENTRAL FOVEA. AT THE END OF 75 SPOTS OF TREATMENT, THE LASER SHUT DOWN, AND HAD TO BE TURNED OFF TO ALLOW IT TO COOL DOWN. AT THE END OF THE COOLING DOWN PERIOD, IT AGAIN SEEMED TO FUNCTION, AND AN ADDITIONAL 39 SPOTS WERE PLACED. FOLLOWING THIS PROCEDURE, THE LASER AGAIN SHUT DOWN AND THIS TIME COULD NOT BE STARTED UP AGAINDEVICE 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-AUG-92. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. 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, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MODIFICATION OF DEVICE. CONCLUSION: DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.