BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT5MM RELOAD

    MDR report key: 11759719 · Received May 3, 2021

    Report

    Report Number
    11759719
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 12, 2021
    Report Date
    April 23, 2021
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE JUSTRIGHT 5MM STAPLER WAS FIRED ACROSS THE BRONCHUS. ALL STEPS OF THE FIRING PROCESSES WERE FOLLOWED, BUT AFTER THE JUSTRIGHT 5MM STAPLER WAS FIRED IT WAS NOTED THAT ONLY A FEW STAPLES WERE SECURED, THERE WERE SOME FREE FLOATING STAPLES, AND THE DEVICE DID NOT APPEAR TO HAVE FIRED CORRECTLY. A RELOAD WAS THEN PLACED ON THE STAPLER HANDLE AND THE STAPLER WAS FIRED AGAIN. A FEW STAPLES HELD AT THE OPPOSITE END, THERE WERE STILL FREE FLOATING STAPLES, AND THE DEVICE DID NOT APPEAR TO HAVE FIRED CORRECTLY AGAIN. THE STAPLER CUT THROUGH BRONCHUS AND THERE WAS A [AIR] LEAK. IT WAS DECIDED TO CONTINUE WITH PROCEDURE AND SUTURE THE BRONCHUS AFTER THE UPPER LEFT LOBE OF LUNG WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661265 JUSTRIGHT5MM RELOAD STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC JR-REL25-2.0 75AJ1620

    Patients

    Seq Age Sex Outcome Treatment
    1 540 DA