BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGR WAVEGUIDE WIDE ANGLED

    MDR report key: 2661469 · Received July 18, 2012

    Report

    Report Number
    2661469
    Event Type
    Malfunction
    Date Received
    July 18, 2012
    Date of Event
    June 4, 2012
    Report Date
    July 18, 2012
    Manufacturer
    INVUITY, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHEN ADJUSTING THE LIGHTED RETRACTOR, THE BLACK SHIELD BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIGR WAVEGUIDE WIDE ANGLED WAVEGUIDE WIDE ANGLED JOL INVUITY, INC. 102521 12020605

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR