BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEMS S.P.A.

    MDR report key: 3232310 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00020
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    June 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PID TEMPERATURE CONTROL WAS REPLACED AND THE LASER SYSTEM RETURNED TO WORK. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    LASER DOES NOT HOLD STABLE POWER OUTPUT. LASER DOES NOT OVERHEAT NOR DOES TEMPERATURE RISE SIGNIFICANTLY, BUT POWER OUTPUT FLUCTUATES GREATLY. WE ARE UNAWARE ABOUT PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1