Description of Event or Problem · 1
ON MAY 19, 1992, I WAS PERFORMING A PHACOEMULSIFICATION ON A PATIENT AT THE AMBULATORY SURGERY CENTER AT LEIGH MEMORIAL HOSPITAL.I WAS USING THE ALCON PHACOEMULSIFICATION INSTRUMENT AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE SEEMED TO BE GOING WELL. AFTER THE LENS HAD BEEN PARTIALLY PHACOEMULSIFIED, IT BECAME APPARENT THAT SUCTION ON THE MACHINE DID NOT WORK. THE LENS FRAGMENTS WERE NOT BEING REMOVED FROM THE EYE PROPERLY AS THEY SHOULD BE AND THE PROCEDURE HAD TO BE STOPPED.SEVERAL MANEUVERS WERE PERFORMED TO ATTEMPT TO GET THE SUCTION ON THE MACHINE TO START. THE HAND PIECE WHICH I WAS USING TO PHACOEMULSIFY THE LENS WAS CHANGED. THE TUBING WAS CHECKED AND SEVERAL TESTS WERE PERFORMED. HOWEVER, AT NO TIME WERE WE ABLE TO GET ADEQUATE SUCTION TO FINISH THE CATARACT EXTRACTION.THE PROCEDURE WAS FINISHED WITH GREAT DIFFICULTY WITH A RENT IN THE BACK CAPSULE OF THE LENS CAUSING LOSS OF THE VITREOUS GEL IN THE EYE AND FORCING OF THE PLACEMENT OF THE INTRAOCULAR LENS IN A POSITION WHERE IT IS NOT USUALLY PLACED.THIS MAY OR MAY NOT CAUSE THIS PATIENT TO HAVE PERMANENT VISUAL PROBLEMS. IT MAY TAKE THREE TO FOUR MONTHS TO KNOW WHETHER THE DIFFICULTY ENCOUNTERED IN THE MACHINERY AND THE SUBSEQUENT DIFFICULTY IN THE SURGERY IS GOING TO CAUSE THIS PATIENT PERMANENT VISUAL DISABILITY IN THIS EYE.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-MAY-92. SERVICE PROVIDED BY: INVALID DATA. 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, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, FOREIGN MATERIAL CONTAMINATION, INADEQUATE QUALITY ASSURANCE, OTHER, CASSETTE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.