BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLMIUM LASER FIBER WIRE

    MDR report key: 5741292 · Received June 20, 2016

    Report

    Report Number
    MW5062956
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    June 15, 2019
    Report Date
    June 17, 2016
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HOLMIUM LASER LITHOTRIPSY OF A LARGE 2CM KIDNEY STONE, A 2MM END OF THE LASER FIBER BROKE OFF AND EMBEDDED INTO THE REMAINING KIDNEY STONE. AS THE RENAMING STONE MEASURED APPROX 1 CM, AND VIABILITY WAS POOR DUE TO BLEEDING, THE ENTIRE STONE COULD NOT BE REMOVED, AND THE PROCEDURE WOULD HAVE TO BE STAGED. THE 2MM LASER FIBER WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389760 HOLMIUM LASER FIBER WIRE 365 MICRO FIBER WIRE GEX LASER PERIPHERALS, LLC RTB-365-PL FL531

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention