BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE LASER

    MDR report key: 3586790 · Received January 10, 2014

    Report

    Report Number
    3586790
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    November 21, 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

    SURGEON USING OMNIGUIDE LASER FOR REMOVAL OF MAXILLARY AND RIGHT LIP TUMOR. CHANGED SETTINGS ON THE OMNIGUIDE LASER CONSOLE FROM 50 PSI AND 5 WATTS TO 10 WATTS. THEN CHANGED SETTING TO 15 WATTS. NOTED BURNING SMELL DURING USE. OMNIGUIDE LASER IMMEDIATELY PUT ON STANDBY AND DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17991 OMNIGUIDE LASER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. * *
    17992 OMNIGUIDE SURGICAL BEAM PATH ENT-L FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. ENT-L FIBER LA131008BU-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR