BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CP-1T100L COLON

    MDR report key: 90938 · Received May 14, 1997

    Report

    Report Number
    2429304-1997-00013
    Event Type
    Injury
    Date Received
    May 14, 1997
    Date of Event
    March 12, 1997
    Report Date
    May 5, 1997
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE HOSPITAL QUALITY REVIEW ADMINISTRATOR, PERFORATION OF THE COLON OCCURRED DURING A ROUTING COLONOSCOPY PROCEDURE. THE PT IS A DIABETIC WITH A HISTORY OF PERITONEAL ADHESIONS, DIVERTICULOSIS AND WAS DIAGNOSED WITH COLON CANCER IN 1978. IN 1978, THE PT UNDERWENT COLON RESECTION DUE TO THE DESCENDING COLON CANCER. WHEN PERFORATION OCCURRED DURING THIS LATEST COLONOSCOPY, THE PT WAS TAKEN TO SURGERY FOR COLON RESECTION AND REVISION OF THE EARLIER COLOSTOMY. THE PT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP-1T100L COLON CF-1T100L COLONOVIDEOSCOPE FDF THE OLYMPUS OPTICAL CO. CF-1T100L *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention