BEUDAMED
    FDA Recall Terminated

    EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical visualization (via a video monitor) of the Upper Airway.

    Recall: Z-0820-2012 · Initiated September 30, 2011

    Recall

    Recall Number
    Z-0820-2012
    Event Number
    60788
    Firm
    Pentax Medical Company
    FEI Number
    1000080301
    Product Code
    EOX
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 30, 2011
    Posted
    January 20, 2012
    Terminated
    November 27, 2012
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical visualization (via a video monitor) of the Upper Airway.

    Reason

    The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

    Action

    Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.

    Distribution

    Nationwide Distribution.

    Quantity

    one unit