BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 9241902 · Received October 25, 2019

    Report

    Report Number
    3001722928-2019-00015
    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
    PMA / PMN Number
    K183032
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION AND INITIAL REPORTER INFORMATION ARE UNKNOWN. EVALUATION SUMMARY: INSPECTION OF THE DEVICE AFTER THE EVENT: THE BALLOON CONTROLLER AND SCOPE WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THE BALLOON WAS DISCARDED BY THE HOSPITAL. EVALUATION DID NOT REVEAL ANY ABNORMALITIES WITH ANY OF THE FUJIFILM DEVICES. CAUSE OF THE FAILURE: THE BALLOON WAS INFLATED AND DEFLATED WITHOUT ANY ABNORMALITIES BEFORE AND AFTER THE PROCEDURE, WHICH SUGGEST THE PROBLEM OCCURRED TRANSIENTLY. WHEN WATER ENTERS THE BALLOON CHANNEL, RESISTANCE IS INCREASED, AND THE BALLOON CANNOT BE INFLATED OR DEFLATED BY THE PRESSURE OF THE BALLOON CONTROLLER. UTILIZING A SYRINGE CAN GENERATE A HIGHER PRESSURE THAN THE BALLOON CONTROLLER, SO THAT THE BALLOON CAN BE INFLATED OR DEFLATED. IT IS CONSIDERED THAT THE MALFUNCTION OCCURRED DUE TO THE RESIDUAL WATER FROM THE DISINFECTION PROCESS ENTERING THE BALLOON CHANNEL. IT SHOULD ALSO BE NOTED THAT THE INSTRUCTIONS FOR USE INDICATE THE FOLLOWING: "WARNING: DO NOT USE A SYRINGE FOR BALLOON INFLATION DURING AN EXAMINATION OR PROCEDURE. MANUAL OVERPRESSURIZATION MAY DAMAGE THE DIGESTIVE TRACT WALL AND CAUSE PERFORATION." IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 30 SEP 2019 FUJIFILM MEDICAL CO., LTD NOTIFIED FUJIFILM CORPORATION 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
    1035176 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENDOSCOPE FDA FUJIFILM CORPORATION EI-580BT N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention