BEUDAMED
    FDA Enforcement Class II Terminated

    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Recall: Z-2807-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2807-2015
    Event ID
    70858
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus America Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    March 26, 2015
    Classification Date
    September 22, 2015
    Termination Date
    February 1, 2017
    Address
    3500 Corporate Pkwy., P.O. Box 610, Center Valley, PA, 18034-0610, United States

    Description

    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Reason

    New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

    Code Info

    Model: TJF-Q180V, all sold units

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.

    Quantity

    6109