BEUDAMED
    FDA Adverse Event Summary report: N

    QUANTA SYSTEM S.P.A

    MDR report key: 3832246 · Received October 1, 2013

    Report

    Report Number
    3004378299-2013-00111
    Date Received
    October 1, 2013
    Date of Event
    September 16, 2013
    Report Date
    October 1, 2013
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADD'L INFO FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: BLUE CYLINDER WAS NOT CORRECTLY CONNECTED WITH SMA CONNECTOR. SMA CONNECTOR WAS SHIFTED INSIDE THE BLUE CYLINDER. WHEN THE USER SWITCHED ON THE LASER WITH A POWER OF 100 W, THE FIBER BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496315 QUANTA SYSTEM S.P.A SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1