BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

    MDR report key: 7721843 · Received July 26, 2018

    Report

    Report Number
    7721843
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    March 14, 2018
    Report Date
    July 23, 2018
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, ONE OF THE INTERNAL CABLES INSIDE THE SCOPE THAT IS CONTROLLED BY THE DIAL BROKE. A LOUD SNAP WAS HEARD RESULTING IN LOSS OF DIRECTION CONTROL OF TIP OF SCOPE. THE PROCEDURE WAS DIFFICULT, AND THE DOCTOR DECIDED TO ABORT THE CASE AND NOT TRY A DIFFERENT SCOPE. THIS RESULTED IN AN INCOMPLETE COLONOSCOPY TO ASCENDING COLON. COLON SCOPE: CFH 180AL, OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566280 COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF OLYMPUS CORPORATION OF THE AMERICAS CF-H180AL

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA