BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3820226 · Received April 24, 2014

    Report

    Report Number
    3004378299-2014-00023
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 24, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADDITIONAL INFO FROM THE DIST.

    Description of Event or Problem · 1

    THE LASER SYSTEM SHOWS THE FOLLOWING MESSAGE: "ERROR CODE 100% SIE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248906 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1