QUATERA 700

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE REPORTED EVENT WAS A USER ERROR. THE SYSTEM IDENTIFIED A MISSING FCP AND SHOWED THE USER AN ERROR MESSAGE AT THE START, ACCORDINGLY. THE HANDLING AND RESOLVING OF ERROR MESSAGES ARE DESCRIBED IN DETAIL IN THE IFU. THE INSTRUCTION FOR USE (IFU)  CLEARLY STATES THAT THE USER SHOULD TAKE ADEQUATE PRECAUTIONS, DEPENDING ON THE APPLICATION, TO ENABLE THE SURGICAL PROCEDURE OR TREATMENT TO BE FINISHED WITHOUT USING THE DEVICE IN CASE OF MALFUNCTION OR SYSTEM ERROR.

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) FROM SPAIN (ES) REPORTED THAT DURING A CATARACT SURGERY WHEN THE SURGEON PROCEEDED TO USE THE PHACO HANDPIECE OF THE QUATERA 700, THE FOOT PEDAL OF THE FOOT CONTROL PANEL (FCP) DID NOT RESPOND. THE PEDAL HAD BOTH BLUE LEDS ON AND ON THE SCREEN, IT APPEARED AS A DEACTIVATED FCP. USER PROCEEDED TO DO SEVERAL HARD RESETS, CHANGED THE FCP CABLE AND THE CASSETTE. HOWEVER, EVERYTHING REMAINED THE SAME AND THE QUATERA 700 WENT INTO THE SAFE STATE. THE PATIENT AT THAT TIME HAD THE MAIN INCISION AND PARACENTESIS, CAPSULORHEXIS AND HYDRODISSECTION PERFORMED. AFTER THE MEASURES TO REMEDY THE PROBLEM WERE NOT SUCCESSFUL, THE SURGEON DECIDED TO SUSPEND THE PROCEDURE. THE PATIENT HAD A STITCH PLACED IN THE MAIN INCISION AND WAS SENT BY AMBULANCE TO ANOTHER GENERAL HOSPITAL WHERE THE CATARACT SURGERY PROCESS WAS COMPLETED. A DELAY OF ONE HOUR WAS REPORTED.