BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTB-272

    MDR report key: 7776784 · Received August 13, 2018

    Report

    Report Number
    7776784
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 30, 2018
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING LASER LITHOTRIPSY WITH HOLMIUM LASER AND STENT PLACEMENT THE SURGEON NOTED THE END OF A 200 MICRON LASER FIBER BROKE OFF. DUE TO THE SIZE OF THE FIBER THERE WAS NO ACTUAL ABILITY TO REMOVE THE FRAGMENT. INCIDENT WAS DISCLOSED TO THE PATIENT BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617810 HTB-272 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC HTB-272 DL17063

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA