BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE-USE STAPLER

    MDR report key: 1031287 · Received April 18, 2008

    Report

    Report Number
    1219930-2008-00306
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 31, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: ESOPHAGECTOMY. PT: FEMALE, NOT OVERWEIGHT. ACCORDING TO THE REPORTER: THE PT EXPERIENCED A POST OPERATIVE LEAK. A LAPAROTOMY WAS PERFORMED TO REINFORCE THE ANASTOMOSIS WITH SUTURE, AND SIGNIFICANT BLOOD LOSS WAS REPORTED. THE SURGEON REPORTED THAT HE IS NOT SURE IF THE LEAK WAS DUE TO THE DEVICE, AS IT WAS A DIFFICULT CASE. NO STAPLE LINE REINFORCEMENT MATERIAL WAS USED, AND NO LEAK TEST WAS PERFORMED DURING THE INITIAL PROCEDURE. DURING THE RE-OPERATION NO OBSERVATIONS OR ABNORMALITIES NOTED ABOUT THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 25MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R DEVICE ID: EEAORVIL25| DEVICE NAME: DST SERIES EEA ORVIL 25MM DEVICE