BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 3232276 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00027
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    September 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K102749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN OUTPUT COUPLER MIRROR. PLACED DISSECCAND INSIDE RESONATORS TO REDUCE HUMIDITY.

    Description of Event or Problem · 1

    THE SURGICAL LASER. AT THE LASER START THE LOW POWER ERROR IS DISPLAYED. IN SERVICE MODE CURRENT IS OK BUT POWER IN 0.0129 W AND NO OUTPUT FROM LASER HEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1