BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 8252216 · Received January 16, 2019

    Report

    Report Number
    8252216
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    January 3, 2019
    Report Date
    January 9, 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

    STAPLER LOADED BY SCRUB, TESTED PRIOR TO ENTRY INTO PORT BY SURGEON, PLACED INTO PORT, FIRED, JAWS OPENED TO STAPLER ENOUGH FOR TISSUE TO FALL FROM STAPLER, #5 BUTTON IN THE BACK OF THE STAPLER DID NOT OPEN FULLY, SURGEON PULLED STAPLER BACK RECOILED AND A HOLE OCCURRED IN THE DIAPHRAGM. THE OPENING WAS SUTURED INTRAOPERATIVELY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47769 JUSTRIGHT 5MM STAPLER STAPLER, SURGICAL GDW JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75DH3021

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Other