BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3820384 · Received April 24, 2014

    Report

    Report Number
    3004378299-2014-00014
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 14, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO THE SMA FIBER CONNECTION (DIRTY AND WORN OUT). PROGRAMMED MAINTENANCE IS NEEDED. AFTER THE REPLACEMENT OF THAT COMPONENT AND DUE MAINTENANCE, 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: "FIBER CONNECTION IS NOT STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249821 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1