Description of Event or Problem · 1
PT UNDERGOING CATARACT SURGERY WITH LENS IMPLANT. WHEN PHACOEMULSIFICATION INITIATED, ACUTE CHANGES NOTED AT WOUND ENTRY LEVEL. PHACOEMULSIFICATION IMMEDIATELY TERMINATED. THE SLEEVE WAS REPLACED AND PHACO TIP HANDPIECE RETIGHTENED. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. PRIOR TO START OF CASE, THE INSTRUMENT WAS TESTED BY THE SURGICAL SCRUB TECHNICIANS AND SURGEON WITHOUT IDENTIFIED CONCERNS. REPAIR OF WOUND INCLUDED A CONJUNCTIVAL GRAFT OVER THE CORNEAL AND SCLERAL WOUND SITE. ON SITE EVALUATION DID NOT IDENTIFY ANY PROBLEMS. CO VISUAL TESTS IDENTIFIED NO DEFECTS. DURING FUNCTIONAL TESTING IT WAS NOTED THE HANDPIECE EXHIBITED "LOW STROKE", NOT BELIEVED TO CONTRIBUTE TO AN IMMEDIATE CORNEAL BURN. THE TIP CAP SLEEVE WAS NOTED TO HAVE A DARK SPOT ABOVE THE IRRIGATION PORTS. THE IRRIGATION FLOW RATE WAS WITHIN SPECIFICATIONS.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-95. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. 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.