BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 1041160 · Received May 12, 2008

    Report

    Report Number
    1219930-2008-00369
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLON RESECTION. ACCORDING TO THE REPORTER: A LINEAR STAPLER WAS USED FOR RESECTION, BUT BLOOD FLOW WAS NOT GOOD ON THE PROXIMAL BOWEL, SO ANOTHER RESECTION WAS DONE. IT WAS ALSO REPORTED THAT THERE WAS TENSION ON INTESTINAL MEMBRANE. AFTERWARDS THE EEA WAS APPLIED, AND NO ABNORMALITIES WERE NOTED, INSTRUMENT OPERATED NORMALLY AND DONUTS WERE NORMAL. THE SURGEON TESTED THE ANASTOMOSIS WITH AIR, BUT A BOWEL MATERIAL LEAK WAS OBSERVED. SUBSEQUENTLY, A PERMANENT COLOSTOMY WAS SET ON TRANSVERSE COLON. THERE WAS NO REPORT IF AN ATTEMPT WAS MADE TO REPAIR THE LEAK. IT IS ALSO REPORTED THAT THE OPERATING TIME AND INCISION WERE NOT EXTENDED AND NO BLEEDING OCCURRED AS A RESULT. 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 U8B36H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention