BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 16529481 · Received March 13, 2023

    Report

    Report Number
    1000513161-2023-00009
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 13, 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 FEBRUARY 22, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING EI-580BT. IT WAS REPORTED THAT DURING AN ENDOSCOPY THE BALLOON ATTACHED TO THE ENDOSCOPE AND OVERTUBE FAILED TO EXPAND. THE PHYSICIAN PUSHED THE ENDOSCOPE AND OVERTUBE CAUSING A PERFORATION TO OCCUR IN THE JEJUNUM. THE PATIENT UNDERWENT EMERGENCY SURGERY AND RECOVERED. THERE IS NO DEATH REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575975 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION N/A N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention