BEUDAMED
    FDA Enforcement Class II Ongoing

    daVinci Harmonic ACE Curved Shears

    Recall: Z-0841-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0841-2019
    Event ID
    81972
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    January 16, 2019
    Classification Date
    February 15, 2019
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    daVinci Harmonic ACE Curved Shears

    Reason

    During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.

    Code Info

    All Lots

    Distribution

    US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom

    Quantity

    43755 inserts