BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DB-600 600U BARE LASER FIBER

    MDR report key: 15146004 · Received August 2, 2022

    Report

    Report Number
    15146004
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    June 10, 2022
    Report Date
    July 21, 2022
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE TIP BROKE OFF DURING THE PROCEDURE, ALL PIECES ARE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162726 DB-600 600U BARE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC DB-600 DD21033

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA Female