BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 16489819 · Received March 6, 2023

    Report

    Report Number
    3001722928-2023-00010
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    February 16, 2023
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    PMA / PMN Number
    K183032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, FUJIFILM CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION OF EI-580BT. INVESTIGATION OF THE PRESSURE LOG CONCLUDED THAT THE PHYSICIAN PERFORMED THE ENDOSCOPY WITH THE BALLOON OF THE OVERTUBE INFLATED WHICH CAUSED OVERLOADING OF THE GASTROINTESTINAL TRACT. THEREFORE, THE ROOT CAUSE IS DETERMINED TO BE USER ERROR.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT IS BEING SUBMITTED TO FDA AS A RESULT OF FUJIFILM CORPORATION'S COMMITMENT TO PERFORM A RETROSPECTIVE REVIEW OF ALL MDRS SUBMITTED BETWEEN OCTOBER 1, 2021 AND OCTOBER 12, 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON SEPTEMBER 22, 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Additional Manufacturer Narrative · 0

    DURING THE PRE-USE INSPECTION AT THE USER FACILITY, AN ABNORMALITY WAS FOUND IN WHICH THE BALLOON ATTACHED TO THE ENDOSCOPE DID NOT EXPAND. THE CAUSE OF THE PROBLEM WAS FOUND TO BE WATER IN THE BALLOON. THE BALLOON WAS REATTACHED, AND THE REINSPECTION CONFIRMED THAT THE DEVICE WAS OPERATING AS INTENDED. IT IS UNCLEAR WHY THE EXPANSION FUNCTION OF THE BALLOON FAILED DURING THE PROCEDURE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ON FEBRUARY 17, 2023, FUJIFILM 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
    612308 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