BEUDAMED
    FDA Recall Terminated

    Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

    Recall: Z-2518-2018 · Initiated January 17, 2018

    Recall

    Recall Number
    Z-2518-2018
    Event Number
    79622
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    OCS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 17, 2018
    Terminated
    December 4, 2019
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R

    Reason

    Potential breakage of the endoscope s insertion tube bending section during surgical procedures

    Action

    On 1/16/18 an Urgent Medical Device Removal Action Notification letter was shipped to affected customer via Fed-EX. The notification informed customers the recall was initiated in response to customer complaints regarding the breakage of the endoscopes insertion tube bending section during surgical procedures. Customers were instructed to complete the following: 1. Inspect your inventory and identify any URF-V2/V2R models; 2.Olympus will contact your facility to make arrangements for return of your URF-V2/V2R u videoscope(s) for the device exchange. You will be provided instructions on returning the URF-V2/V2R for this exchange; 3.Olympus has discontinued previously distributed copies of the URF-V2/V2R Reprocessing Manual and the Operation Manual. Inspect your inventory of the Reprocessing Manual and the Operation Manual, and discard any existing inventory of the URF-V2/V2R Reprocessing Manual and the Operation Manual; 4.Implement use of the enclosed Reprocessing Manual which recommends only sterilization methods, and the enclosed Operation Manual; 5. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new reprocessing instructions in the new Reprocessing Manual; 6. If you may have further distributed the URF-V2/V2R, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter; 7. Please indicate on the enclosed questionnaire that you have received this notification. Return of the enclosed questionnaire will be deemed to be a request for a new replacement URF-V2/V2R videoscope(s). Fax the completed form to 484-896-7128.

    Distribution

    US Nationwide and Canada

    Quantity

    2548