BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2 LASER GUIDE

    MDR report key: 3590723 · Received January 10, 2014

    Report

    Report Number
    3590723
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    November 27, 2013
    Report Date
    January 10, 2014
    Manufacturer
    OMNIGUIDE INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    LASER FIBER GOT BURNED DURING PROCEDURE. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19800 CO2 LASER GUIDE POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. * *
    19801 SURGICAL BEAMPATH ENT-L FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC * LA130813BP-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR