BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLONOSCOPE

    MDR report key: 31998 · Received January 10, 1995

    Report

    Report Number
    31998
    Event Type
    Death
    Date Received
    January 10, 1995
    Date of Event
    December 15, 1994
    Report Date
    December 22, 1994
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT BECAME HYPOTENSIVE AFER FLEX SIGMOIDOSCOPY, ABDOMEN FIRMER. FLAT PLATE OF ABDOMEN DONE WHICH SHOWED MASSIVE FREE AIR-PROBABLE PERFORATION. PHYSICIAN DISCUSSED OPTION OF REPAIR OF PERFORATION WITH FAMILY. DECISION WAS MADE TO MAKE PT A "NO CODE"; SURGICAL REPAIR WAS NOT PURSUED. PT WAS ON A VENTILATOR AND EXPIRED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLONOSCOPE COLONOSCOPE FDF OLYMPUS AMERICA, INC. CF 20L

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death