BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE EZ 200

    MDR report key: 1013072 · Received March 5, 2008

    Report

    Report Number
    1013072
    Event Type
    Malfunction
    Date Received
    March 5, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HOLMIUM LASER 100 WATT MACHINE WAS BEING FIRED WHEN THE SHEATH ON LASER FIBER SHREDDED. SOME OF THE LASER FIBERS WERE MISSING FROM THE SHEATH. THE FIBERS WERE UNABLE TO BE VISUALIZED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE EZ 200 LASER FIBER GEX BOSTON SCIENTIFIC CORP. PRODUCT #: M0068408920 66871207

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR