BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE 25A INTELLIGUIDE CO2 PORTABLE LASER

    MDR report key: 8735179 · Received June 25, 2019

    Report

    Report Number
    MW5087610
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 20, 2019
    Report Date
    June 21, 2019
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMALL CRACK WAS FOUND IN LASER WIRE DURING PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526691 OMNIGUIDE 25A INTELLIGUIDE CO2 PORTABLE LASER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. 25A LA181018BV

    Patients

    Seq Age Sex Outcome Treatment
    1