SIEMENS

Description of Event or Problem

PATIENT WAS RECEIVING PADIATION THERAPY, A SINGLE DROP OF OIL DRIPPED IN PATIENTS LEFT EYE. EYE WAS FLUSHED WITH SALINE BY RADIATION ON COLOGIST IMMEDIATELY FOLLOWING INCIDENT. PATIENT WAS SEEN AND EVALUATED BY OPHTHALMOLOGIST. NO REACTION WAS NOTED WITH EYE BY OPHTHALMOLOGIST.DEVICE 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-MAR-94. 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: VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, CABLE. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.