BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT5MM RELOAD

    MDR report key: 9590576 · Received January 15, 2020

    Report

    Report Number
    9590576
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 6, 2019
    Report Date
    December 31, 2019
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS DOING A RIGHT UPPER LOBE WEDGE RESECTION. DOCTOR SUCCESSFULLY USED THE JUST RIGHT 5MM STAPLER TWICE. THE ON THE THIRD LOAD DOCTOR NOTED THAT THE STAPLER DID NOT SEEM TO OPEN AS WIDE AS THE PREVIOUS TIMES AND HE ASKED THE REP ABOUT IT. REP SAID THAT IT MIGHT OPEN WIDER WHEN TISSUE WAS PLACED IN THE JAWS. DOCTOR PROCEEDED AND FIRED THE STAPLE LOAD. AFTER THE JAWS OF THE LOAD WERE OPENED DOCTOR NOTED THAT THE LOAD ONLY PARTIALLY FIRED AND THAT THERE WAS A NOTED INDENT ON THE LUNG TISSUE THAT DID NOT HAVE STAPLES. LOAD WAS SEQUESTERED AND A NEW LOAD WAS USED. NO PATIENT HARM. DOCTOR WAS RECORDING THE WHOLE PROCEDURE WITH THE NSTEAM SYSTEM. MANUFACTURER RESPONSE FOR JUST RIGHT 5MM RELOAD, (BRAND NOT PROVIDED) (PER SITE REPORTER). WAITING ON THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55640 JUSTRIGHT5MM RELOAD STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC JR-REL25-2.0 75AI1639

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA