BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATANA SYSTEM S.P.A

    MDR report key: 3820445 · Received February 24, 2014

    Report

    Report Number
    3004378299-2014-00009
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A BROKEN CAVITY MIRROR. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. THIS LASER SYSTEM IS NOT MARKETED IN USA, BUT THE SAME EVENT MAY OCCUR IN A SIMILAR DEVICE MARKETED IN USA. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "POWER OUTPUT 80%".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114295 QUATANA SYSTEM S.P.A SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. MEGA PULSE TOWER 30+

    Patients

    Seq Age Sex Outcome Treatment
    1