Description of Event or Problem · 1
SURGEON PERFORMING VITRECTOMY FOR DIAGNOSIS OF SEVERE RETINA DETACHMENT. SURGEON REPORTS WHEN REMOVING FLUID FROM THE EYE, THE MACHINE DID NOT INSTILL FLUID INTO THE EYE TO MAINTAIN EQUILIBRIUM. THE SURGEON NOTED POOR FLUID PRESSURE FROM THE DEVICE. AS A RESULT, THE EYE RESPONDED BY COLLAPSING DOWN ON ITSELF CAUSING THE PROCEDURE TO BE QUITE DIFFICULT. DEVICE REMOVED FROM EYE AND A SYSTEM TEST PERFORMED BY THE EYE RN SPECIALTY LEADER. REP CONTACTED AND GAVE DIRECTIONS REGARDING HOW TO TEST THE DEVICE ON TEST OVER THE PHONE. TEST PERFORMED DEMONSTRATES FLUID RUNNING WELL. TUBING REINSERTED INTO THE EYE BY THE SURGEON AND YET THE SAME COLLAPSING EYE EVENT OCCURRED. THE DEVICE WAS RUNNING PROPERLY WHEN PROBE OUT OF EYE BUT FAILING TO PERFORM WHEN PROBE RE-INSERTED INTO THE EYE.THE MACHINE IS BEING INSPECTED BY OUR BIOMED ENGINEER AND THE MANUFACTURER AS WELL. THERE ARE VERY SPECIFIC GUIDELINES THAT THE SURGEON NEEDS TO ADHERE TO WHEN USING THIS PIECE OF EQUIPMENT. A FEW MILLIMETERS OF MISDIRECTION CAN CAUSE A MALFUNCTION IN THE TROCAR AND THE FLUID MANAGEMENT WITHIN THE EYE. THE EQUIPMENT WILL REMAIN OUT OF SERVICE UNTIL CLEARED BY ALL INSPECTIONS. NO HARM TO PATIENT, SURGEON MODIFIED PROCEDURE TO USE WHAT WAS AVAILABLE TO HIM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LASER ASSISTED VITECTOMY FOR SERIOUS RETINAL DETACHMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.