BEUDAMED
    FDA Adverse Event Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3832248 · Received October 1, 2013

    Report

    Report Number
    3004378299-2013-00112
    Date Received
    October 1, 2013
    Date of Event
    September 21, 2013
    Report Date
    October 1, 2013
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K091909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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: THE OUTPUT ENERGY IS VERY LOW AND THE LASER SYSTEM SHOWS LOW MESSAGE. CHECKED AND FOUND THAT HR MIRROR AND AR MIRROR HAVE SPOT ON THEIR SURFACE. SPOT ON THE LASER ROD. BOTH THE HR AND AR MIRRORS AND LASER ROD NEED TO BE REPLACED TO ASSURE THE CORRECT FUNCTIONING OF THE LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496312 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. LITHO

    Patients

    Seq Age Sex Outcome Treatment
    1