BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12745083 · Received November 3, 2021

    Report

    Report Number
    3001722928-2021-00026
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 6, 2023
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDT
    UDI-DI
    14547410359289
    PMA / PMN Number
    K191747
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RE-SUBMITTED AS A FOLLOW-UP TO MDR NUMBER 3001722928-2021-00026. IT WAS INITIALLY SUBMITTED INCORRECTLY AS A FOLLOW-UP TO MDR NUMBER 3001722928-2021-00024. ON OCTOBER 26 AND 27, 2021, FUJIFILM CORPORATION CONDUCTED THE ROOT CAUSE INVESTIGATION AT THE SITE TO REVIEW THE REPROCESSING PROCEDURE AND SAMPLING PROCEDURE. ADDITIONALLY, THE ENDOSCOPE WAS ALSO INVESTIGATED BY FUJIFILM. THE RESULTS OF THE INVESTIGATION DID NOT LEAD TO A CLEAR CONCLUSION THAT THE CONCERNED ORGANISM WAS MOST LIKELY A RESULT OF CROSS-CONTAMINATION OF THE ENDOSCOPE. AS A PRECAUTION, AND WITH THE INTENT TO AID IN PREVENTION OF THE PRESENCE OF ANY HIGH CONCERN ORGANISMS, FUJIFILM PERFOMED RE-TRAINING AT THE SITE AND REITERATED THE IMPORTANCE OF FOLLOWING THE IFUS AND GUIDELINES FOR SCOPE STORAGE, CLEANING, TRANSPORTATION AND SAMPLING.

    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 · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2021 FUJIFILM CORPORATION WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS CULTURED AND TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE AND ENTEROCOCCUS FEACALIS (TOTAL 36 CFUS). THE ENDOSCOPE WAS QUARANTINED AFTER INITIAL SAMPLING, 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 EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643492 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown