BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE USE STAPLER

    MDR report key: 1041157 · Received May 12, 2008

    Report

    Report Number
    1219930-2008-00366
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 17, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. PT GENDER: UNK. ACCORDING TO THE REPORTER: THERE WAS A HOLE IN THE PROXIMAL SIDE OF THE ANASTOMOSIS AFTER APPLYING THE DEVICE. THE SURGEON RESECTED THE STAPLE LINE AND HAND SEWED THE ANASTOMOSIS. NO BLOOD LOSS WAS REPORTED, AND SURGERY TIME WAS EXTENDED 20 TO 30 MINS AS A RESULT. NO PT INJURY WAS REPORTED AND NO PT DETAILS WERE DISCLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention