BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 9241979 · Received October 25, 2019

    Report

    Report Number
    1000513161-2019-00010
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    September 30, 2019
    Report Date
    October 25, 2019
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AND INITIAL REPORTER INFORMATION ARE UNKNOWN. REF: INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    ON 15 OCT 2019 FUJIFILM CORPORATION NOTIFIED FUJIFILM MEDICAL SYSTEMS U.S.A., INC (FMSU) THAT AN ADVERSE EVENT OCCURRED AT A HOSPITAL IN (B)(6). THE BALLOON (BS-2) ON THE SCOPE STOPPED INFLATING AFTER THE DOUBLE BALLOON ENDOSCOPY WITH THE SCOPE (EI-580BT) WAS STARTED. THE USER WAS AWARE THAT THE INSTRUCTION MANUAL INDICATES THAT THE ENDOSCOPE SHOULD BE REMOVED WHEN A PROBLEM OCCURS. HOWEVER, ALTHOUGH THE USER STOPPED USING THE BALLOON CONTROLLER (PB-20), SHE/HE TRIED TO INFLATE THE BALLOON USING A SYRINGE AND A PERFORATION OCCURRED. AFTER THAT, THE PATIENT UNDERWENT SURGERY; PATIENT OUTCOME WAS NOT DISCLOSED. THERE WERE NO ERRORS INDICATING ABNORMALITIES WHILE USING THE BALLOON CONTROLLER. AFTER THE PROCEDURE, THE BALLOON WAS AGAIN CONNECTED TO THE BALLOON CONTROLLER FOR OPERATIONAL TESTING, AND THE BALLOON SUCCESSFULLY INFLATED. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032385 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENDOSCOPE FDA FUJIFILM CORPORATION EI-580BT N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention