BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 152823 · Received February 24, 1998

    Report

    Report Number
    152823
    Event Type
    Death
    Date Received
    February 24, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 24, 1998
    Manufacturer
    OLYMPUS AMERICA, INC./ENDOSCOPE INSTRUMENT DIV.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT POLYPECTOMY ON 2/2/98. PT PRESENTED TO THE ER ON 2/5/98 WITH FEVER AND ABDOMINAL PAIN. PT SUBSEQUENTLY ARRESTED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GASTROSCOPE FDS OLYMPUS AMERICA, INC./ENDOSCOPE INSTRUMENT DIV. GIF 100 SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death POLYP SNARE- MFR UNKNOWN| OLYMPUS LIGHT SOURCE M/N CLV-U20| VALLEYLAB ESU M/N SURGISTAT B