BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE USE STAPLER

    MDR report key: 1041158 · Received May 12, 2008

    Report

    Report Number
    1219930-2008-00367
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    January 15, 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: LAP COLON - IO DOUBLE STAPLING TECHNIQUE. PT GENDER: UNK. ACCORDING TO THE REPORTER: AFTER SIGMOID COLON WAS RESECTED, THE INSTRUMENT WAS PLACED, BUT THE STUMP OF COLON WHICH HAD LINEAR STAPLE LINE WAS OVERLAPPED BY THE CIRCULAR STAPLER. THE EEA WAS PULLED, CHANGED ITS POSITION AND THEN IT WAS APPLIED. A LEAKAGE WAS FOUND AND WAS CORRECTED BY STITCHING. NO BLEEDING OCCURED AS A RESULT, BUT SURGERY WAS DELAYED BY 30 MINS OR MORE. NO PT DETAILS WERE DISCLOSED, BUT HAS BEEN DISCHARGED FROM HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA 31MM SINGLE USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7M06H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention