BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXTERA II

    MDR report key: 3807281 · Received April 4, 2014

    Report

    Report Number
    3807281
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 4, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST PROCEDURE, THE PHYSICIAN SUSPECTED POSSIBLE COLON PERFORATION AND TRANSFERRED THE PATIENT. THE PATIENT REQUIRED SURGICAL INTERVENTION FOR A PERFORATED COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205230 EVIS EXTERA II COLONVIDEOSCOPE FDF OLYMPUS AMERICA, INC. GL928800 8XK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R