Description of Event or Problem · 1
HGM ARGON LASER WAS BEING USED WITH ZEISS MICROSCPOE FOR EYE SURGERY WHEN OPHTHALMOLOGY RESIDENT USING OBSERVER BINOCULARS RECEIVED DIRECT LASER REFLECTION TO HIS EYES. THE ASSEMBLY HAD BEEN PUT TOGETHER INCORRECTLY BY HOSPITAL STAFF OR SERVICE REPRESENTATIVE WITH THE LASE FILTER SHUTTER MISPLACED AS FOLLOWS: 1 PATIENT - 2 MAIN BODY - 3 ACCESSORY UNIT (CONTAINING OBSERVERS BINOCULARS) - 4 LASER SHUTTER/FILTER - 5 OPERATOR BINOCULAR INSTEAD OF AS INTENDED 1-2-4-3-5-. ITEMS 2, 3 & 5 ARE MANUFACTURED BY ZEISS AND ITEM 4 IS MANUFACYURED BY HGM. RESIDENT SUFFERED ONLY TEMPORARY VISUAL IMPAIRMENTDEVICE 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-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: DESIGN - INADEQUATE, FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.