BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTB-272-PL

    MDR report key: 8188972 · Received December 21, 2018

    Report

    Report Number
    8188972
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    October 24, 2018
    Report Date
    December 19, 2018
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER TIP BROKE OF IN PATIENT DURING PROCEDURE RIGHT URETEROSCOPIC LASER LITHOTRIPSY. A NEW FIBER OBTAINED AND PROCEDURE COMPLETED. UNABLE TO SEE OR FIND BROKEN SECTION. SURGEON DOCUMENTED THAT TIP WAS FLUSHED OUT. THE XRAY WAS NEGATIVE FOR FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027737 HTB-272-PL POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC HTB-272-PL DF180841

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA