BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1031289 · Received April 18, 2008

    Report

    Report Number
    1219930-2008-00307
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: THE DISTAL DONUT WAS TORN AND LEAKAGE WAS OCCURRED FROM THE LUMEN. THE THICKNESS OF THE TORN DISTAL DONUT WAS NOT UNIFORM. A NEW INSTRUMENT OF DIFFERENT TYPE AND HAND SUTURING WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7E04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention