BEUDAMED
    FDA Recall Terminated

    Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.

    Recall: Z-1425-2013 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-1425-2013
    Event Number
    65073
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 23, 2011
    Posted
    May 29, 2013
    Terminated
    May 30, 2013
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.

    Reason

    Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

    Action

    Intuitive Surgical sent an Important Product Notification letters dated October 10, 2011 to all affected customers. A second letter was sent to those that had not responded on December 4, 2011. The letters identified the affected product, problem, and actions to be taken, The letter included recommendations and suggestions for proper use and prevention of damage to the Tip cover during surgery. Also attachments include recommendations and further information for the following areas: avoid instrument collisions; carefully install tip cover; straighten wrist prior to removal; inspect cannula prior to use and do not exceed maximum monopolar cautery settings. Attached is a list of validated ESU settings and suggestions and instruction on being aware of critical anatomy in contact with the instrument and to change the tip cover in cases with extended cautery use. Questions may be referred to Customer service at 1-800-876-1310 in the US and at + 41 21 821 2020 or +800-0821-2010.

    Distribution

    Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.

    Quantity

    50,000 boxes of 10 tip covers