BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS DUODENOSCOPE

    MDR report key: 6117807 · Received November 21, 2016

    Report

    Report Number
    2951238-2016-00876
    Event Type
    Death
    Date Received
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DUODENOSCOPE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE MANUFACTURING OF THIS TYPE OF DUODENOSCOPE HAS BEEN DISCONTINUED SINCE 1989. IT HAS BEEN DETERMINED THAT THE DUODENOSCOPE WAS NOT CLEARED BY FDA TO BE SOLD IN THE UNITED STATES, AND OLYMPUS DID NOT IMPORT THIS DEVICE IN THE UNITED STATES; HOWEVER, IT IS UNKNOWN HOW THE USER FACILITY OBTAINED THE DUODENOSCOPE. THE CAUSE OF THE PATIENT DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A PATIENT DEVELOPED SEPSIS AND CHOLANGITIS AFTER UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE WAS PERFORMED AT (B(6) USING A DUODENOSCOPE. THE PATIENT WAS REPORTEDLY EXPIRED ON (B(6) 2011. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767930 OLYMPUS DUODENOSCOPE DOUDENOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. JF-B4 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| O