BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 1083286 · Received July 28, 2008

    Report

    Report Number
    1219930-2008-00569
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 14, 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: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: THE SPIKE OF THE EEA WAS INSERTED 1MM ANTERIOR TO THE RECTAL STUMP STAPLE LINE. THE ANVIL WAS ATTACHED AND THE EEA WAS CLOSED WITH CAREFUL ATTENTION TO ENSURE THAT THERE WAS NO INVAGINATION OF TISSUE. THE PROXIMAL AND DISTAL APPROXIMATED TISSUE WAS INSPECTED FOR TWISTING OF BOWEL AND THEN THE EEA WAS FIRED. AFTER THE EEA WAS FIRED, THE ANVIL WAS REMOVED AND THE DISTAL AND PROXIMAL DONUTS WERE INSPECTED. THERE WERE TWO INTACT DONUTS, HOWEVER, THE DISTAL DONUT WAS VERY THIN ON THE POSTERIOR SIDE. UPON INSPECTING THE ANASTOMOSIS, THE POSTERIOR SIDE OF THE ANASTOMOSIS SHOWED THAT THE RECTAL STAPLE LINE WAS NOT INCORPORATED, AND THEREFORE, THERE WAS A CIRCULAR STAPLE LINE AND THE LINEAR RECTAL STAPLE LINE NEXT TO EACH OTHER. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE IDENTIFIED. HOWEVER, DUE TO THE THINNESS OF THE DISTAL DONUT AND THE CONCERN OF THE TWO CLOSE STAPLE LINES, POTENTIALLY CAUSING ISCHEMIC TISSUE, THE SURGEON ADDED SUTURES TO CLOSE THE TISSUE GAP BETWEEN THE STAPLE LINES. A SECOND LEAK TEST WAS PERFORMED AND LEAKS WERE IDENTIFIED COMING FROM THE REGION WHERE THE DISTAL DONUT WAS THIN AND THE STAPLE LINE FIX HAD BEEN PERFORMED. THE SURGEON THEN FELT THAT RATHER THAN ADDING ADDITIONAL SUTURES TO CORRECT THE LEAKS THAT THE ANASTOMOSIS NEEDED TO BE RE-DONE. A NEW INSTRUMENT OF DIFFERENT TYPE WAS USED TO COMPLETE THE PROCEDURE. SURGERY TIME WAS EXTENDED TWO HOURS AS A RESULT. THE PATIENT IS IN WELL CURRENT CONDITION AND STABLE.

    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 84 YR Required Intervention