BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIR WAVEGUIDE

    MDR report key: 6208604 · Received December 28, 2016

    Report

    Report Number
    6208604
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 23, 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

    WHILE SURGEON WAS HOLDING INVUITY LIGHTED RETRACTOR, THE PLASTIC LIGHT BULB MELTED IN THE MIDDLE AND BROKE INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858514 EGIR WAVEGUIDE LIGHTED RETRACTOR FDG INVUITY, INC. 104015 16010505

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR