BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1192441 · Received October 7, 2008

    Report

    Report Number
    1219930-2008-00733
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 16, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP LOW ANTERIOR RESECTION. PT GENDER: UNK. ACCORDING TO THE RPTR: WHEN THE SURGEON TRIED TO CLOSE THE DEVICE, THE ANVIL KEPT DETACHING FROM THE TROCAR. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. SURGERY TIME WAS EXTENDED BY MORE THAN THIRTY MINS AS A RESULT, BUT THERE WAS NO ADD'L TISSUE DAMAGE AND NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8E37H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention