BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT

    MDR report key: 5996604 · Received October 4, 2016

    Report

    Report Number
    5996604
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 2, 2016
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THORACOTOMY FOR LEFT LOWER LOBE CONGENITAL LUNG LESION, AFTER THE STAPLER WAS FIRED THE CHEST FILLED WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648354 JUSTRIGHT STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC 75DF0614

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR NO| NO OTHER THERAPIES