BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMIUM LASER FIBER

    MDR report key: 1081157 · Received July 10, 2008

    Report

    Report Number
    1081157
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE DEVICE BROKE IN THE FLEXIBLE URETERSCOPE AND SEGMENT WAS REMOVED UNEVENTFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLMIUM LASER FIBER LASER, FIBER GEX BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR