BEUDAMED
    FDA Recall 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 · Initiated March 26, 2015

    Recall

    Recall Number
    Z-2807-2015
    Event Number
    70858
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    March 26, 2015
    Posted
    September 22, 2015
    Terminated
    February 1, 2017
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    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.

    Action

    The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at [email protected].

    Distribution

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

    Quantity

    6109