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 A SURGICAL MICROSCOPE (SEE REPORT SEQUENCE NO. 0002). THE S-22 WAS BROUGHT TO THE O.R. BUT WAS INOPERABLE. EVALUATION OF THE DEVICE: THE MICROSCOPE WAS CLEANED BY STAFF THE DAY PRIOR TO THE INCIDENT. IT WAS REPARIED BY THE MANUFACTURER ON 2/19/92 INCLUDING ADJUSTMENT OF THE FOOT SWITCH AND REPLACEMENT OF THE FOCUS UP SWITCHDEVICE 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: . 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, 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.