BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR WAVEGUIDE

    MDR report key: 6120773 · Received November 22, 2016

    Report

    Report Number
    6120773
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    INVUITY, INC.
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON NOTICED THAT THE DISPOSABLE WAVEGUIDE FOR THE LIGHTED RETRACTOR HAD MELTED SLIGHTLY AT THE EDGE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771558 EIGR WAVEGUIDE RETRACTOR, FIBEROPTIC FDG INVUITY, INC. 104015 160512901

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR