BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 16489692 · Received March 6, 2023

    Report

    Report Number
    3001722928-2023-00009
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Report Date
    November 7, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDA
    UDI-DI
    04547410295900
    PMA / PMN Number
    K183032
    Removal / Correction Number
    N/A
    Product Problem
    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. PEELING WAS OBSERVED ON THE SIDE OF THE TIP OF THE SCOPE AS AN ABNORMALITY AND IS BELIEVED TO HAVE CAUSED THE POSITIVE CULTURE. NO OTHER REMARKABLE ABNORMALITIES WERE OBSERVED.

    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 (B)(6) 2021 AND (B)(6) 2023, DUE TO FDA 483 OBSERVATIONS ISSUED TO FUJIFILM CORPORATION ON (B)(6) 2023. THIS SUPPLEMENT INCLUDES MISSING OR INCORRECT INFORMATION IN THE ORIGINAL MDR FILING, AND PREVIOUS SUPPLEMENTS WHERE APPLICABLE.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    FUJIFILM CORPORATION WAS INFORMED THAT EI-580BT ENDOSCOPES WERE CULTURED AND TESTED POSITIVE. THE DATE THAT THE EVENT OCCURRED IS UNKNOWN. THE ENDOSCOPE WAS QUARANTINED AFTER INITIAL SAMPLING, AND NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549690 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION N/A N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown