BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 8173549 · Received December 18, 2018

    Report

    Report Number
    8173549
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 3, 2018
    Report Date
    December 14, 2018
    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

    POSITIVE AIR LEAK WITNESSED IN PLEUR-A-VAC AT END OF OPERATIVE PROCEDURE. THE PATIENT WAS REINTUBATED AND PATIENT POSITIONED, PREPPED AND DRAPED LAPAROSCOPIC CAMERA INSERTED INTO LEFT CHEST. STAPLE LINE AT OPERATIVE SITE DISRUPTED. LEAK FIXED WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012588 JUSTRIGHT 5MM STAPLER STAPLE, IMPLANTABLE GDW JUSTRIGHT SURGICAL, LLC JR-ST25-2.0 75JH2617

    Patients

    Seq Age Sex Outcome Treatment
    1 270 DA