BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DUODENOSCOPE MODEL ED-580XT

    MDR report key: 13966138 · Received March 31, 2022

    Report

    Report Number
    3001722928-2022-00005
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 11, 2022
    Report Date
    November 7, 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

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED PENDING INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    ON MARCH 22, 2022, FUJIFILM CORPORATION CONDUCTED THE ROOT CAUSE INVESTIGATION AT THE SITE TO REVIEW THE REPROCESSING AND SAMPLING PROCEDURES. ADDITIONALLY, THE ENDOSCOPE WAS INSPECTED BY FUJIFILM. NO ROOT CAUSE OF THE PRESENCE OF HIGH CONCERN ORGANISMS WAS DETERMINED. THERE WAS NO SPECIFIC EVIDENCE AFTER EVALUATION OF THE DEVICE AND REPROCESSING PROCEDURES THAT INDICATED THE HIGH CONCERN ORGANISM WAS A RESULT OF CLINICAL CONTAMINATION OF THE ENDOSCOPE, DESPITE THE ORGANISM TYPE. ALTHOUGH THERE WERE SEVERAL THINGS NOTED IN THE INVESTIGATION THAT MAY CONTRIBUTE TO THE OVERALL NUMBER OF INSTANCES WHERE GROWTH WAS OBSERVED IN THE ENDOSCOPE, NONE OF THESE COULD BE CONSIDERED THE DEFINITIVE ROOT CAUSE FOR THE PRESENCE OF THE HIGH CONCERN ORGANISMS. TO MINIMIZE THE POTENTIAL FOR MICROBIAL CONTAMINATION, PARTICULARLY HIGH CONCERN ORGANISM GROWTH, THE SITE WAS INSTRUCTED TO FOLLOW THE ED-580XT AND THE AER'S IFUS AND RELATED GUIDELINES, REGARDING SCOPE STORAGE, CLEANING, HANDLING SINGLE-USE ENDOSCOPE ACCESSORIES, AND AER MAINTENANCE.

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2022, FUJIFILM CORPORATION WAS INFORMED THAT THE SUBJECT ENDOSCOPE (ED-580XT) WAS CULTURED AND TESTED POSITIVE FOR ESCHERICHIA COLI, MICROCOCCUS SPECIES, AND KLEBSIELLA PNEUMONIAE (TOTAL 2 CFUS). SINCE THE ENDOSCOPE WAS SAMPLED AND CULTURED AS PART OF POST-MARKET SURVEILLANCE ACTIVITY, NO PATIENTS WERE INVOLVED OR EXPOSED TO THE ENDOSCOPE. PER THE STUDY PROTOCOL, THE ENDOSCOPE WAS IMMEDIATELY QUARANTINED AFTER INITIAL SAMPLING UNTIL CULTURE DATA WERE AVAILABLE. FOLLOWING THE POSITIVE CULTURE, THE ENDOSCOPE WAS NOT CLINICALLY REUSED. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842852 FUJIFILM DUODENOSCOPE MODEL ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown