Description of Event or Problem · 1
THE PATIENT UNDERWENT EXTRA CAPSULAR CATARACT ASPIRATION OF THE RIGHT EYE. DURING THE PROCEDURE, A ZONULAR DEHISCENCE WAS NOTED WITH PRESENTATION OF THE VITREOUS. AN INTRACAPSULAR CATARACT EXTRACTION WITH INSERTION OF AN INTRAOCULAR LENS PROSTHESIS WAS ATTEMPTED BUT HINDERED BY THE MALFUNCTION OF THE SURGICAL MICROSCOPE. A SECOND MICROSCOPE WAS BROUGHT TO THE O.R., HOWEVER, IT WAS INOPERABLE (SEE REPORT SEQUENCE NO. 0003). EVALUATION OF DEVICE: THE MICROSCOPE, WHICH UNDERWENT ROUTINE, SCHEDULED MAINTENANCE ON 8/15/91, WAS REPAIRED BY THE MANUFACTURER ON 2/19/92. THE REPAIR INCLUDED REPLACING THE RESET FOR THE BLUE LIGHT, REPAIRING THE BLUE FILTER AND ADJUSTING THE KNIFE CONNECTOR TO GET THE FANS RUNNING.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-AUG-91. SERVICE PROVIDED BY: MANUFACTURER. 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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. 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.