BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA Q

    MDR report key: 8113937 · Received November 28, 2018

    Report

    Report Number
    3013515803-2018-00014
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 5, 2018
    Report Date
    November 29, 2018
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    GEX
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS SOON AS THE EVENT WAS IDENTIFIED,THE UNIT WAS TAKEN OF SERVICE IMMEDIATELY. THERE WAS NO PATIENT INVOLVED WHEN THE EVENT OCCURED. THE FAULT COULD NOT BE REPLICATED. FURTHER INVESTIGATION HAS DETERMINED THE FAULT TO BE CAUSED DURING SERVICING ACTIVITY ON 2ND OCTOBER , 3 DAYS BEFORE THE EVENT OCCURED , WHERE THE JOYSTICK WAS STUCK AND HAD TO BE REGREASED. IT IS SUSPECTED THAT DURING SERVICING ACTIVITY THE CABLE MANAGEMENT WASN'T CONDUCTED PROPERLY WHICH WOULD HAVE LED TO THE UNINTENDED LASER EMISSION. THIS IS AN ISOLATED INCIDENT AND ALL OTHER UNITS MANUFACTURED DURING THIS PERIOD WERE CHECKED AND THERE WAS NO PROBLEM FOUND WITH THE JOYSTICK . THE UNIT HAS BEEN REPLACED WITH A NEW JOYSTICK AND HAS BEEN FOUND TO BE WORKING TO SPECIFICATION (PERFORMANCE VERIFIED THROUGH A PRODUCT ACCEPTANCE FAULT RECORD). ELLEX WILL BE MONITORING THIS SYSTEM AND OTHER UNITS ON THE FIELD FOR ANY SIMILAR FINDINGS. THE SERVICE TECHNICIAN HAS BEEN RECOMMENDED TO UNDERGO TRAINING ON JOYSTICK SERVICING. THE DEVICE HAS BEEN IN USE FOR 14 YEARS AND THERE HAVE BEEN NO SIMILAR COMPLAINTS, REPORTED TILL DATE. E2018008.

    Description of Event or Problem · 0

    THE DEFECT WAS OBSERVED IN USA ON ULTRA Q LASER WHICH WAS FIRING ON ITS OWN WHEN THEY MOVED THE JOYSTICK . NO SERIOUS INJURY CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949203 ULTRA Q OPHTHALMIC LASER GEX ELLEX MEDICAL PTY LTD LQP3106

    Patients

    Seq Age Sex Outcome Treatment
    1