Description of Event or Problem · 1
DURING CATARACT SURGERY WITH PHACOEMULSIFICATION, HANDPIECE WAS SET UP AND PRIMED AS PER PROCEDURE. DR CHECKED UNIT BEFORE INSERTING INTO THE EYE AS PER PROCEDURE. DURING PROCEDURAL USE, INFLOW TO THE HANDPIECE WAS SOMEHOW OCCLUDED, CAUSING THE TIP TO OVERHEAT, RESULTING IN A CORNEAL SCLERAL BURN. A NEW HANDPIECE WAS USED AND A NEW DISPOSABLE CANNISTER UNIT WAS INSTALLED INTO THE MACINE. THE PROCEDURE THEN PROGRESSED WITHOUT FURTHER INCIDENT. THE COMPANY WAS CONTACTED AT THE END OF THE PROCEDURE. THE DR SPOKE WITH THE COMPANY NURSE REP AND OPTED TO CONTINUE CASES WITH DIFFERENT HANDPIECES AND CASSETTES. LOANER PUT IN SERVICE NEXT DAY. UNIT TO BE SENT TO COMPANY FOR EVALUATION AFTER HOSP EVALUATION.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. DATE LAST SERVICED: 01-MAR-94. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.