BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE-USER STAPLER

    MDR report key: 1041156 · Received May 12, 2008

    Report

    Report Number
    1219930-2008-00364
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: TOTAL GASTRECTOMY ROU-EN-Y, LAP TO OPEN. ACCORDING TO THE REPORTER: JOINING THE DEVICE TO THE ORVIL WAS DIFFICULT, BUT IT CONNECTED AFTER FIVE ATTEMPTS. VERY WEAK DONUTS WERE PRODUCED AFTER APPLYING THE DEVICE. IN 2008, THE PT WAS RETURNED WITH A BROKEN DOWN ABDOMINAL WOUND INFECTION, WHICH WAS WASHED OUT AND VAC DRESSING WAS PLACED. ABOUT 5 DAYS LATER, A STENT WAS PLACED TO BRIDGE A PROBLEM AT THE ANASTOMOSIS. IT IS REPORTED THAT THE PT'S CURRENT CONDITION IS CRITICAL. NO FURTHER INFO HAS BEEN PROVIDED THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 25MM SINGLE-USER STAPLER DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U7H07

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R 25MM DEVICE| PRODUCT ID # : EEAORVIL25