BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE SIS ENDO

    MDR report key: 3861220 · Received May 20, 2014

    Report

    Report Number
    3861220
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 20, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UROLOGIST WAS ATTEMPTING TO USE THE FLEXIBLE URETEROSCOPE AND LASER LEADS. THE LASER LEADS WOULD NOT FIT PROPERLY THROUGH THE SCOPE, BUT THEY WOULD PASS THROUGH THE CHANNEL. TWO DIFFERENT SIZES OF LASER WIRES WERE OPENED AND TRIED, BUT THE ATTEMPTS FAILED AND THE SURGEON WAS UNABLE TO USE THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299663 SLIMLINE SIS ENDO POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, LTD. * *
    299664 SLIMLINE SIS ENDO POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO.