BEUDAMED
    FDA Recall Terminated

    da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,

    Recall: Z-0658-2008 · Initiated March 9, 2007

    Recall

    Recall Number
    Z-0658-2008
    Event Number
    38315
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 9, 2007
    Posted
    January 31, 2008
    Terminated
    April 19, 2011
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086

    Description

    da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,

    Reason

    Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.

    Action

    The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.

    Distribution

    Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.

    Quantity

    206 units