BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3843084 · Received January 3, 2014

    Report

    Report Number
    3004378299-2014-00008
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    January 27, 2014
    Report Date
    February 3, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADDITIONAL INFO FROM THE DISTRIBUTOR. WE ARE UNAWARE ABOUT PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "LASER WAS PRODUCING 106 WATTS MEASURED AT THE INTERNAL POWER METER AT A SET POINT OF 150 WATTS. AT APPROXIMATELY 176 KJ THE LASER SHUT DOWN AND USE OF THE LASER WAS TERMINATED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5141 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 150

    Patients

    Seq Age Sex Outcome Treatment
    1