BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 677687 · Received February 16, 2006

    Report

    Report Number
    2431293-2006-00001
    Event Type
    Injury
    Date Received
    February 16, 2006
    Date of Event
    January 9, 2006
    Manufacturer
    FUJINON, INC.
    Product Code
    FTJ
    Removal / Correction Number
    2431293-02/15/06-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE, THE SURGEON/PHYSICIAN REPORTED THAT THE COLONOSCOPE WAS STIFF AND PERFORATED THE COLON. THE PHYSICIAN CHOSE TO PERFORM OPEN SURGERY TO REPAIR THE PERFORATED PORTION OF THE COLON. FUJINON WAS INFORMED THE SURGERY WAS SUCCESSFUL AND THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * VIDOE COLONOSCOPE FTJ FUJINON, INC. EC-450LP5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization