BEUDAMED
    FDA Adverse Event Death Summary report: N

    TJF-160F

    MDR report key: 2250752 · Received August 26, 2011

    Report

    Report Number
    2250752
    Event Type
    Death
    Date Received
    August 26, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    OLYMPUS
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT #1ERCP PERFORMED. POST PROCEDURE, PATIENT UNRESPONSIVE. CT OF THE HEAD WITHOUT CONTRAST ORDERED. CT IMPRESSION: MULTIPLE BILATERAL SUPRATENTORIAL AND INFRATENTORIAL EVOLVING INFARCTS. THERE IS MILD SWELLING AND EDEMA OF THE POSTERIOR FOSSA. SLIGHT INTERVAL INCREASE IN SIZE OF VENTRICLES. MILD PETECHIAL HEMORRHAGE WITHIN THE POSTERIOR RIGHT TEMPORAL LOBE INFART. PATIENT #2ERCP PERFORMED. POST PROCEDURE PATIENT UNRESPONSIVE. CT OF THE HEAD WITHOUT CONTRAST ORDERED. CT IMPRESSION: SMALL HYPONDENSITIES WITH IN RIGHT AND POSSIBLY LEFT CEREBRAL HEMISPHERE, AS WELL AS BILATERAL CAVERNESS SINUS REGIONS, THE FINDINGS SUGGESTIVE OF AIR VERSUS LESS LIKELY FAT EMBOLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TJF-160F ENDOSCOPE KOG OLYMPUS TJF-160F *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death
    2 49 YR