BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE SURGICAL

    MDR report key: 3913653 · Received June 27, 2014

    Report

    Report Number
    MW5037051
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 27, 2014
    Manufacturer
    OMNIGUIDE SURGICAL
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIOR TO REACHING THE PT, THE FIBER WAS READIED FOR USE. NO ENERGY WAS TRANSMITTED AND A SMELL OF SULPHUR WAS NOTED. THE ITEM WAS REMOVED FROM SERVICE AND DID NOT REACH THE PT. WILL BE RETURNED TO THE MFR FOR TESTING AS SOON AS SHIPPING CARTON ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376438 OMNIGUIDE SURGICAL BEAMPATH ROBOTIC FIBER GEX OMNIGUIDE SURGICAL 12.2015 LA131230AS-PA

    Patients

    Seq Age Sex Outcome Treatment
    1