BEUDAMED
    FDA Recall Terminated

    OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

    Recall: Z-0029-2012 · Initiated August 25, 2011

    Recall

    Recall Number
    Z-0029-2012
    Event Number
    59787
    Firm
    Olympus America Inc.
    FEI Number
    2429304
    Product Code
    FCG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 25, 2011
    Posted
    October 7, 2011
    Terminated
    September 28, 2012
    Address
    3500 Corporate Pkwy. P.O. Box 610, Center Valley, PA, 18034-0610

    Description

    OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

    Reason

    Firm has received complaints from users of the ability to wipe material from the needle's stylet and the presence of material in patient cytology samples obtained by the needle following endobronchial ultrasound fine needle aspiration of a lesion. Olympus Medical Systems Corporation (OMSC) in Japan has confirmed that metal particles can occur on the stylet due to friction between the stylet and n

    Action

    OLYMPUS sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A revised Instruction Manual with the new WARNINGS will be sent to the customer's attention. Customers were instructed to examine their inventory to determine if they have the affected product. To share the information on the new WARNINGS with all of the appropriate staff at their facility and any other organization where the product has been transferred. Complete and return the enclosed questionnaire even if they do not have affected product. Customers were instructed to fax the completed questionnaire to 484-896-7128. For any question call 484-896-5688.

    Distribution

    Nationwide Distribution including the District of Columbia and the following States: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

    Quantity

    22,498