BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE

    MDR report key: 6431627 · Received March 24, 2017

    Report

    Report Number
    6431627
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    November 21, 2016
    Report Date
    March 8, 2017
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A ROBOTIC LASER FIBER X 3 WAS DEFECTED; IT WORKED BRIEFLY, THEN HAD TO REPLACE. WE REPORTED THE DEFECTIVE ITEMS. NO HARM WAS DONE TO THE PATIENT OR STAFF. THE EQUIPMENT WAS TAKEN BY THE COMPANY TO CHECK ON PROPER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214619 OMNIGUIDE POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR