BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232328 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00010
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    June 14, 2012
    Report Date
    December 19, 2012
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MIRROR IN THE SHUTTER UNIT WAS DAMAGED. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM SHOWED "POWER LOW" MESSAGE ON THE FIRST CHECK TO CUSTOMER. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1