BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER FIBERS

    MDR report key: 7024183 · Received November 13, 2017

    Report

    Report Number
    7024183
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 26, 2017
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804701 LASER FIBERS POWERED LASER SURGICAL INSTRUMENT GEX OLYMPUS SURGICAL TECHNOLOGIES AMERICA F2717S

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLMIUM LASER GENERATOR