BEUDAMED
    FDA Recall Terminated

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.

    Recall: Z-1811-2008 · Initiated April 18, 2008

    Recall

    Recall Number
    Z-1811-2008
    Event Number
    48085
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 18, 2008
    Posted
    September 17, 2008
    Terminated
    March 25, 2011
    Address
    1266 Kifer Rd, Sunnyvale, CA, 94086-5304

    Description

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.

    Reason

    The product has a software interface problem. When the product is connected to the da Vinci IS2000 System it will not allow the System to recognize the Instrument which makes the IS2000 CPG instrument nonfunctional at all sites. Risks associated are loss of operability of the instrument, delay in surgery, and loss of dexterity.

    Action

    On April 18, 2008 an Urgent Device Recall letter was issued to customers. Consignees were notified via e-mail and were instructed to return the product. Customers were instructed to segregate the product in a secure area for Intuitive Surgical CSRs. If you have any questions contact Karen Uyesugi at (408) 523-2100.

    Distribution

    Class II Recall - Nationwide Distribution --- including states of NC, OH, GA and WI.

    Quantity

    11