BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXTERA II

    MDR report key: 3807283 · Received April 4, 2014

    Report

    Report Number
    3807283
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 20, 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

    THE PHYSICIAN REPORTED PERFORMING A DIFFICULT COLONOSCOPY DUE TO EXTRA TURNS AND RIGHT ANGLES. THE PATIENT HAD SEVERE ABDOMINAL PAIN POST PROCEDURE. THE PATIENT WAS TRANSFER FOR SURGICAL REPAIR OF PERFORATED COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204592 EVIS EXTERA II COLONOVIDEOSCOPE FDF OLYMPUS AMERICA, INC. GL928800 8XK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R