BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUODENOSCOPE TJFQ180

    MDR report key: 5666107 · Received May 19, 2016

    Report

    Report Number
    5666107
    Event Type
    Death
    Date Received
    May 19, 2016
    Date of Event
    January 14, 2015
    Report Date
    May 17, 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 ONE OF 2 PATIENTS WHO HAD AN ERCP CONNECTED WITH SCOPE #26, TJFQ180 (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 THREE MONTH TIME FRAME. TWO OF THE 8 PATIENTS WERE RELATED TO SCOPE TJFQ180 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320859 DUODENOSCOPE TJFQ180 DUODENOSCOPE FDT OLYMPUS AMERICA INC TJFQ180

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| L| R THE PT HAD A PRIOR ERCP PERFORMED BUT IT WAS SCOP