BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA SULU

    MDR report key: 9567186 · Received January 8, 2020

    Report

    Report Number
    1219930-2020-00243
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    September 16, 2019
    Report Date
    January 8, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY, AFTER USING A LINEAR STAPLING METHOD ON LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR GASTRIC CANCER IN 29 PATIENT, ANASTOMOTIC COMPLICATIONS WERE REPORTED INCLUDING STRICTURE, LEAKAGE AND BLEEDING. ADDITIONAL EXAMINATIONS, INCLUDING BLOOD TESTS AND COMPUTED TOMOGRAPHY, WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29382 UNKNOWN EGIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention