BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 138252 · Received December 15, 1997

    Report

    Report Number
    8010047-1997-00031
    Event Type
    Injury
    Date Received
    December 15, 1997
    Date of Event
    October 16, 1997
    Report Date
    November 17, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE OLYMPUS FLEXIBLE VIDEO COLONOSCOPE WAS INTRODUCED INTO THE RECTUM AND ADVANCED INTO THE DISTAL SIGMOID. ALTHOUGH IT DID NOT APPEAR TORTUOUS AT THAT POINT, SUDDENLY A SMALL AMOUNT OF BLOOD WAS NOTICED. IT IS IMPORTANT TO NOTE THAT NO UNUSUAL RESISTANCE WAS ENCOUNTERED AT THIS POINT AND IT WAS APPARENT THAT FREE PERFORATION HAD LIKELY OCCURRED. THE AREA WAS DECOMPRESSED, THE INSTRUMENTS WERE WITHDRAWN AND ARRANGEMENTS FOR IMMEDIATE SURGERY WERE MADE. THE PT REMAINED IN THE HOSPITAL FOR FIVE DAYS AND IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOVIDEOSCOPE FDF THE OLYMPUS OPTICAL CO. CF-140L *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R