BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DUODENOSCOPE ED-580XT

    MDR report key: 12467381 · Received September 14, 2021

    Report

    Report Number
    3001722928-2021-00022
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 24, 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

    ON NOVEMBER 8, 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, DESPITE THE ORGANISM TYPE. A HIGHER THAN STUDY AVERAGE OF ENDOSCOPE CONTAMINATION WITH ENVIRONMENTAL OR HUMAN SKIN ORGANISMS WAS OBSERVED, WHICH COULD RELATE TO CROSS-CONTAMINATION OF THE ENDOSCOPE SAMPLES. IT WAS ALSO NOTED THAT THERE WERE DEVIATIONS FROM BEST PRACTICES FOR REPROCESSING OR SAMPLING OF THE ENDOSCOPE AND/OR OUTSIDE THE STATED PROTOCOL PROCEDURES. HOWEVER, NEITHER OBSERVATION COULD BE CONSIDERED AS THE DEFINITIVE ROOT CAUSE FOR THE PRESENCE OF THE HIGH CONCERN ORGANISM. WHILE NO DEFINITIVE ROOT CAUSE WAS DETERMINED, AS A PRECAUTION, AND WITH AN INTENT TO AID IN PREVENTION OF THE PRESENCE OF ANY HIGH CONCERN ORGANISMS, FUJIFILM PERFOMED RETRAINING AT THE SITE AND REITERATED THE IMPORTANCE OF FOLLOWING THE IFUS AND GUIDELINES FOR REPROCESSING.

    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. S1 BLOCK G4 INDICATES THAT IT IS A COMBINATION PRODUCT. THIS IS IN ERROR. IT IS NOT A COMBINATION PRODUCT.

    Additional Manufacturer Narrative · 1

    IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 FUJIFILM CORPORATION WAS INFORMED THAT THE SUBJECT ENDOSCOPE WAS CULTURED AND TESTED POSITIVE FOR ESCHERICHIA COLI (2 CFU). 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
    1368020 FUJIFILM DUODENOSCOPE ED-580XT DUODENOSCOPE AND ACCESSORIES FDT FUJIFILM CORPORATION ED-580XT N/A 14547410359289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown