BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 3232340 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00016
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    October 4, 2011
    Report Date
    December 14, 2012
    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
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    CABLE SCREWS WERE LOOSE OF THE DIODE. TIGHTEN THE SCREWS AND RECALIBRATED.

    Description of Event or Problem · 1

    SURGICAL LASER MALFUNCTIONING. POWER LOST WHEN INCREASED THE EMISSION. SMOKE FROM REAR OF THE DIODE. UNAWARE OF PRESENCE OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTA SYSTEM SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. POLYSURGE 1470

    Patients

    Seq Age Sex Outcome Treatment
    1