BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1030054 · Received April 15, 2008

    Report

    Report Number
    1219930-2008-00284
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 22, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US SURGICAL REFERENCE #: US200804-0582.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: AFTER ATTACHING THE ANVIL TO THE DEVICE, THE TISSUE APPROXIMATION SEQUENCE WAS HARD TO CLOSE AND THE GREEN INDICATOR WAS NOT INITIALLY VISIBLE. AFTER REOPENING AND CLOSING AGAIN, THE SURGEON WAS ABLE TO SEE ENOUGH GREEN TO BE SATISFIED, AND FIRED THE DEVICE. AFTER FIRING THE STAPLE LINE WAS VISIBLY NOT INTACT. THE ANASTOMOSIS HAD TO BE EXCISED AND ANOTHER STAPLING DEVICE WAS USED WITHOUT ANY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7K34

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention