BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUET TRS 45 4.8MM ARTICULATING SULU

    MDR report key: 1832007 · Received September 8, 2010

    Report

    Report Number
    1219930-2010-00701
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 5, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: PNEUMONECTOMY. ACCORDING TO THE REPORTER: ON THE NEXT DAY OF SURGERY, LEAKAGE WAS FOUND. RE-OPERATION WAS DONE AND FOUND THAT THE EDGE OF THE SHEET OF DUET TOUCHED THE PART OF THE LUNG AND TORE THE TISSUE. ADDITIONAL SUTURING WAS DONE ON THE TISSUE. THE PATIENT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUET TRS 45 4.8MM ARTICULATING SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention