BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIDEOSCOPE

    MDR report key: 818461 · Received February 19, 2007

    Report

    Report Number
    818461
    Event Type
    Death
    Date Received
    February 19, 2007
    Date of Event
    November 8, 2006
    Report Date
    February 19, 2007
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH RESPIRATORY DISTRESS, DEHYDRATION, AND CHRONIC DIARRHEA. THE CAUSE OF THE SYMPTOMS WAS UNKNOWN. AN ENDOSCOPIC PROCEDURE WAS PERFORMED TO DETERMINE INITIAL CAUSE OF THE PATIENT'S ILLNESS. AS THE SCOPE WAS WITHDRAWN, A DROP IN THE PULSE OXIMETRY WAS NOTED. ALMOST IMMEDIATELY ABDOMINAL DISTENTION WAS NOTED. ON THE X-RAY, THERE WAS MASSIVE FREE AIR IN ABDOMEN. IT WAS DETERMINED THAT THERE WAS A BOWEL PERFORATION CAUSED BY THE ENDOSCOPIC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIDEOSCOPE ENDOSCOPE, NEONATAL KOG OLYMPUS AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Death NO OTHER THERAPIES