BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1482560 · Received September 21, 2009

    Report

    Report Number
    1219930-2009-00628
    Event Type
    Injury
    Date Received
    September 21, 2009
    Date of Event
    July 1, 2009
    Report Date
    August 27, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE INITIAL REPORT SENT: 9/18/2009.

    Description of Event or Problem · 1

    PROCEDURE: SIGMOIDECTOMY. ACCORDING TO THE REPORT: FOUND LEAKAGE IN THE ANTERIOR PART WHERE THE STAPLES DID NOT CROSS AFTER TWO DAYS OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS N9D0813UH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention