BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIGIR BRITEFIELD MCCULLOCH ILLUMINATION

    MDR report key: 5350662 · Received January 4, 2016

    Report

    Report Number
    MW5059005
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    June 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INVUITY INC.
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PLASTIC PIECE FROM LIGHTED ILLUMINATION RETRACTOR BROKE OFF DURING SURGERY. BROKE OFF DURING SURGERY FOR BILATERAL MASTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596 EIGIR BRITEFIELD MCCULLOCH ILLUMINATION RETRCTR FIBER OPTIC EIGIR BRITEFIELD MCCULLOCH ILLUMINATION FST INVUITY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR