BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3972819 · Received July 25, 2014

    Report

    Report Number
    3004378299-2014-00056
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 23, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K091909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADDITIONAL INFORMATION FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "LASER STOPPED EMMITING ENERGY DURING MAINTENANCE PROCEDURE TO CHECK ALIGNMENT AND POWER OUTPUT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436005 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. LITHO

    Patients

    Seq Age Sex Outcome Treatment
    1