BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 4912771 · Received July 10, 2015

    Report

    Report Number
    3004378299-2015-00062
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 9, 2015
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K131081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAILURE DETECTED, ONLY PRESENCE OF CONTAMINATION INTO THE FILTER, SIMPLY REMOVABLE BY PREVENTIVE MAINTENANCE. AFTER THE MAINTENANCE, THE LASER SYSTEM RESTARTED TO WORK CORRECTLY. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "LASER FAILS TO START UP AND SHOWS FLOW ERROR." NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448556 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 180

    Patients

    Seq Age Sex Outcome Treatment
    1