BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTON GUIDE ILLUMINATOR

    MDR report key: 7323099 · Received March 7, 2018

    Report

    Report Number
    MW5075741
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 6, 2018
    Manufacturer
    INVUITY INC.
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLASTIC PHOTON GUIDE IN INVUITY HIGH RETRACTOR WAS NOTED TO BE "BLACKENED" AND SLIGHTLY MELTED. WAS REPLACED WITH NEW GUIDE. NO HARM TO PT. NARROW FLAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163425 PHOTON GUIDE ILLUMINATOR RETRACTOR FIBEROPTIC FDG INVUITY INC. AB17120602

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention