Description of Event or Problem · 1
DURING CATARACT EXTRACTION, PT SUFFERED CORNEAL BURN. THIS EVENT WAS NOT KNOWN TO RISK MGMT DEPT UNTIL SEVERAL HRS AFTER THE EVENT. HAND PIECE AND TUBING WITH EQUIPMENT WERE TAKEN BY SALES REP AFTER THE PROCEDURE. QA BY CO REPORTED NO PROBLEMS WITH THE EQUIPMENT. CAUSE OF BURN UNKNOWN. OUTCOME OF PT IS STILL UNKNOWN AT THIS TIME. MD STATES COULD MINIMAL OR SERIOUS.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: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.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, NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.