BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 16113110 · Received January 6, 2023

    Report

    Report Number
    1000513161-2023-00001
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    December 8, 2022
    Report Date
    January 6, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ON DECEMBER 15, 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EI-580BT. IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) A PERFORATION OCCURRED IN THE INTESTINAL TRACT. AN OVER-THE-SCOPE CLIP SYSTEM WAS USED TO CLOSE THE PERFORATION AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DEATH REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439568 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EI-580BT N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention