BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1905762 · Received November 16, 2010

    Report

    Report Number
    1219930-2010-00872
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    February 16, 2010
    Report Date
    November 11, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    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: WEDGE RESECTION. ACCORDING TO THE REPORTER: AFTER SURGERY, LEAKAGE OCCURRED. SHEET OF DUET TOUCHED THE TISSUE AND CAUSED THE LEAKAGE. NO BLEEDING WAS REPORTED. THE PATIENT HOSPITAL STAY WAS EXTENDED 3 DAYS DUE TO THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization 510K NUMBER K080898| DUET TRS 45 3.5MM ARTICULATING SULU, DUET4535A