BEUDAMED
    FDA Adverse Event Death Summary report: N

    TJF180V

    MDR report key: 5675456 · Received May 24, 2016

    Report

    Report Number
    5675456
    Event Type
    Death
    Date Received
    May 24, 2016
    Date of Event
    October 3, 2014
    Report Date
    May 18, 2016
    Manufacturer
    OLYMPUS AMERICA INC
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL TO A PREVIOUS REPORT. THIS IS ONE OF 6 PATIENTS WHO HAD AN ERCP CONNECTED WITH SCOPE #47. (B)(4). AFTER AN EXTENSIVE EPIDEMIOLOGIC AND MICROBIOLOGIC INVESTIGATION OF ALL CRE PATIENTS, A CLUSTER OF PATIENTS WERE IDENTIFIED - KLEBSIELLA PNEUMONIA. THESE WERE HIGHLY RELATED TO EACH OTHER SUGGESTING A COMMON SOURCE. FURTHER INVESTIGATION DETERMINED THAT THE PROCEDURE ERCP WAS HIGHLY RELATED. ERCPS PERFORMED BETWEEN AN APPROXIMATE 3 MONTH TIME SPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331765 TJF180V DUODENOSCOPE FDT OLYMPUS AMERICA INC TJF180V

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death