BEUDAMED
    FDA Recall Terminated

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    Recall: Z-2020-2014 · Initiated June 13, 2014

    Recall

    Recall Number
    Z-2020-2014
    Event Number
    68553
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 13, 2014
    Posted
    July 8, 2014
    Terminated
    December 1, 2014
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    Reason

    Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..

    Action

    Urgent Medical Device Correction letters were sent on June 18, 2014 to all affected sites via trackable mail.

    Distribution

    Worldwide Distribution.

    Quantity

    5290 for part 420230-04; 1964 for part 420240-06