BEUDAMED
    FDA Adverse Event Death Summary report: N

    TJF180 V2405047(F)

    MDR report key: 5684831 · Received May 27, 2016

    Report

    Report Number
    5684831
    Event Type
    Death
    Date Received
    May 27, 2016
    Date of Event
    December 10, 2014
    Report Date
    May 22, 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 REPORT AND THE FINAL AND 6TH PATIENT RELATED TO SCOPE 47. DUODENOSCOPE - (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 APPROXIMATELY THREE MONTH TIME SPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339413 TJF180 V2405047(F) DUODENOSCOPE FDT OLYMPUS AMERICA INC TJF180

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H| L