BEUDAMED
    FDA Recall Terminated

    Bronchovideoscope BF-P160

    Recall: Z-3296-2018 · Initiated August 8, 2018

    Recall

    Recall Number
    Z-3296-2018
    Event Number
    80925
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    EOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2018
    Terminated
    May 17, 2022
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Bronchovideoscope BF-P160

    Reason

    The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

    Action

    Urgent Medical Device Safety Notice letters dated 8/8/18 were distributed to customers. The letters instructed customers to perform the following: Our records indicate that your facility has purchased one or more of the above-referenced endoscopes. OLYMPUS requires that you take the following actions: Inspect your inventory for the referenced Olympus models. Please keep this customer letter in your inventory and conduct the following action prior to every use. Step 1: Wearing sterile gloves, attempt to rotate or turn the instrument channel port in counter-clock direction as shown in picture 01. If the instrument channel port is able to be rotated or turned, do not use the endoscope and return it to Olympus for repair. If the instrument channel port does not rotate or turn, go to step 2. Step 2: Visually inspect the rubber part around the instrument channel port of the referenced endoscope. If the rubber part is in a normal condition as shown in picture 02, the endoscope can be used in a patient procedure. If the rubber part is lifted from the molding parts as shown in picture 03, do not use the endoscope and return it to Olympus for repair. If you have any questions about how to conduct this important inspection or you are not sure of the results of your inspection, you should contact the Olympus Technical Assistance Center (TAC), prior to using the device again. The phone number for TAC is 1-800-848-9024 option 1. To request service for your endoscope, contact Olympus at 1-800-848-9024, option 3. If you may have further distributed this product, please identify your customers and inform them at once of this action. Please complete and return the enclosed Reply Form to Olympus at facsimile (484) 896-7128.

    Distribution

    The products were distributed US nationwide and Canada.

    Quantity

    1874