BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLYMPUS

    MDR report key: 197029 · Received November 12, 1998

    Report

    Report Number
    197029
    Event Type
    Death
    Date Received
    November 12, 1998
    Date of Event
    October 29, 1998
    Report Date
    October 29, 1998
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A COLONOSCOPY PERFORMED AT 0700AM ON 10/29/1998. PT HAD THREE POLYPS THAT THE SURGEON BIOPSIED. POST OPERATIVELY THE PT'S ABDOMEN WAS DISTENDED, THE PT COMPLAINED OF ABDOMINAL PAIN, HEART RATE WAS 144-149 BEATS PER MINUTE AND RESPIRATION RATE WAS 39-44 PER MINUTE. THE PT'S BLOOD PRESSURE WAS ELEVATED BEFORE (208/121), DURING (235/115 - 164/79) AND AFTER (218/138) THE PROCEDURE. THE PTS' LOWER EXTREMITIES BECAME MOTTLED, THE PT BECAME RESTLESS, SHORT OF BREATH, AND CONTINUED TO COMPLAIN OF ABDOMINAL PAIN. THE PT'S LEVEL OF CONSCIOUSNESS DECREASED, HEART RATE DECREASED, PULSE OXIMETER READINGS DROPPED TO 79% WITH CONTINUOUS OXYGEN BEING ADMINISTERED. PT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND CARDIO-PULMONARY RESUSCITATION WAS INITIATED. THE PT EXPIRED. CAUSE OF DEATH STATED ON DEATH CERTIFICATE: GRAM NEGATIVE SEPTICEMIA, PEFORATION OF COLON, AND COMPLICATION OF COLONOSCOPY. FULL AUTOPSY REPORT PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE FDF OLYMPUS AMERICA INC. CF-30L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death