Description of Event or Problem · 1
DOCTOR WAS USING THE CONSTELLATION UNIT TO INFUSE SILICONE OIL INTO PATIENT'S LEFT EYE, WHEN SUDDENLY A LOUD NOISE WAS HEARD THAT SOUNDED LIKE AN EXPLOSION. IT WAS THEN NOTED THAT THE 10ML SYRINGE AND CANNULA THAT THE SILICONE OIL WAS IN HAD BEEN EJECTED FROM PATIENT'S EYE WITH APPROXIMATELY 3ML OF SILICONE IN THE SYRINGE. THE SYRINGE INITIALLY WAS FILLED WITH 6ML OF SILICONE. PATIENT IMMEDIATELY BEGAN TO COMPLAIN OF PAIN IN HER LEFT EYE. DR IMMEDIATELY ASSESSED THE EYE AND REQUESTED SUTURE TO CLOSE THE EYE. SUTURES WERE APPLIED. DOCTOR GAVE IV PAIN MEDICATION AND CONTINUALLY TALKED TO PATIENT IN ATTEMPTS TO KEEP HER CALM. DOCTOR ALSO GAVE PATIENT MORE OF THE BLOCK SOLUTION THAT WAS INITIALLY USED. WITHIN 10 MINUTES OR SO AFTER THE INCIDENT OCCURRED, THE INJECTIONS WERE GIVEN, DRESSING WAS APPLIED AND PATIENT WAS TAKEN TO THE RECOVERY ROOM, STATING THAT MUCH OF HER PAIN HAD SUBSIDED.CLINICAL ENGINEERING EVALUATION OF THE UNIT DID NOT FIND ANY DEFECT IN THE SYRINGE OR CONSTELLATION MACHINE. THIS DEVICE WORKS BY NITROGEN GAS PRESSURE PUSHING ON THE BACK OF THE SYRINGE. THE ATTACHMENT TO THE SYRINGE APPARENTLY POPPED OFF UNDER PRESSURE, CAUSING A LOUD NOISE AND SUDDEN MOVEMENT OF THE SYRINGE. THE SYRINGE ATTACHMENT REQUIRES THE USER TO PROPERLY ALIGN THE FLANGE OF THE SYRINGE WITH THE ATTACHMENT. THE DESIGN COULD BE IMPROVED BY ADDING STOPS TO THE ATTACHMENT PIECE SO THAT THE SYRINGE FLANGE CAN'T BE ROTATED PAST THE PROPER ALIGNMENT.======================MANUFACTURER RESPONSE FOR VISCOUS FLUID CONTROL PAK, ALCON (PER SITE REPORTER).======================MANUFACTURER RESPONSE PENDING EVALUATION.======================MANUFACTURER RESPONSE FOR PHACOEMULSIFIER, ALCON (PER SITE REPORTER).======================MANUFACTURER RESPONSE PENDING EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EYE RETINAL DETACH COMPLEX REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.