BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVUITY INC

    MDR report key: 4856358 · Received June 12, 2015

    Report

    Report Number
    MW5043140
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    INVUITY IC
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384396 INVUITY INC RETRACTOR FIBER OPTIC ELGR BRITEFIOLD MCCULLOCH ILLUMINATION FST INVUITY IC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR