BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    MDR report key: 1163122 · Received September 16, 2008

    Report

    Report Number
    2647580-2008-00536
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    PONCE-USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS. ACCORDING TO THE REPORTER: WHEN CLOSING THE DEVICE, THE WINGNUT FELT HARD, BUT THE SURGEON APPLIED IT. AFTER FIRING, THE DONUT HAD TO BE MANFULLY CUT TO REMOVE THE DEVICE. IT WAS THEN NOTED THAT HALF OF THE STAPLES WERE NOT PROPERLY FORMED AND SOME FELL FROM THE ANASTOMOSIS. ALL OF THE FALLEN STAPLES WERE REMOVED FROM THE PATIENT AND THE ANASTOMOSIS WAS OVER SEWN. SURGERY TIME WAS EXTENDED AN HOUR AND A HALF AS A RESULT OF THE MANUAL SUTURING. OOZING BLEEDING UNDER 200CC ALSO OCCURRED. PATIENT IS UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP DISPOSABLE SURGICAL STAPLER GDW PONCE-USS P8D0931J

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention