BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT

    MDR report key: 14431131 · Received May 18, 2022

    Report

    Report Number
    3001722928-2022-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 25, 2022
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 29, 2022, FUJIFILM CORPORATION CONCLUDED THE ROOT CAUSE INVESTIGATION ON THE EI-580BT. THE RESULTS OF THE SAMPLING/CULTURE TEST CONDUCTED BY FUJIFILM WERE NEGATIVE. FURTHER INSPECTION OF THE EQUIPMENT DID NOT REVEAL ANY FINDINGS THAT COULD CONTRIBUTE TO A POSITIVE RESULT OF THE INITIAL SAMPLING/CULTURE TEST. THE SCOPE WAS RETURNED TO THE FACILITY WHERE IT WAS SAMPLED/CULTURED AGAIN, AND THE RESULTS WERE NEGATIVE. THEREFORE, FUJIFILM DETERMINES THAT THE SCOPE WAS CONTAMINATED BY AN UNKNOWN SOURCE DURING THE INITIAL SAMPLING/CULTURE.

    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. 3001722928-2022-00011 S1 BLOCK G4 INDICATES THAT IT IS A COMBINATION PRODUCT. THIS IS IN ERROR. IT IS NOT A COMBINATION PRODUCT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM CORPORATION WAS INFORMED THAT TWO EI-580BT ENDOSCOPES WERE CULTURED AND TESTED POSITIVE. THIS REPORT ADDRESSES THE SECOND OF TWO SCOPES WITH SERIAL # (B)(4) 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
    1186134 FUJIFILM DOUBLE BALLOON ENDOSCOPE EI-580BT ENTEROSCOPE AND ACCESSORIES FDA FUJIFILM CORPORATION EI-580BT N/A 04547410295900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown