BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3820367 · Received April 24, 2014

    Report

    Report Number
    3004378299-2014-00015
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 14, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO THE BROKEN DIODE. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "DIODE NOT EMITTING POWER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248431 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. DNL0163-0611

    Patients

    Seq Age Sex Outcome Treatment
    1