BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 3232336 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    January 24, 2011
    Report Date
    December 13, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGE OF THE OPTIC COMPONENT SUCH AS PUMPING CHAMBER AND LENSES. WATER LEAKAGE INSIDE THE RESONATOR: REPLACEMENT OF THE O-RINGS. THE LASER SYSTEM WAS NOT ABLE TO PERFORM OPTIMALLY.

    Description of Event or Problem · 1

    LASER RESONATOR OF SURGICAL LASER WAS NOT WORKING PROPERLY. LOW POWER UNAWARE OF ANY ADVERSE OUTCOME FOR THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1