BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1212097 · Received October 24, 2008

    Report

    Report Number
    1219930-2008-00765
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    October 20, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOID RESECTION PATIENT GENDER: UNKNOWN. ACCORDING TO THE REPORTER: THERE WERE NO ABNORMALITIES NOTED DURING THE INITIAL PROCEDURE. ONE OR TWO DAYS POST-OPERATIVELY, THE PATIENT DEVELOPED AN ANASTOMOTIC INSUFFICIENCY. THE PATIENT WAS RE-OPERATED AND IT WAS NOTICED THAT THE STAPLE LINE WAS VISIBLE BUT THE TISSUE BEYOND IT WAS NECROTIC. A NEW ANASTOMOSIS WAS CREATED USING ANOTHER STAPLER. NO BLEEDING OR SIGNIFICANT SURGERY DELAY IN EITHER CASE WAS REPORTED. NO FURTHER INCIDENT OR PATIENT DETAILS HAVE BEEN DISCLOSED FROM THE USER FACILITY. PROCEDURE WAS SOMETIME IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R