BEUDAMED
    FDA Recall Open, Classified

    daVinci Harmonic ACE Curved Shears

    Recall: Z-0841-2019 · Initiated January 16, 2019

    Recall

    Recall Number
    Z-0841-2019
    Event Number
    81972
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 16, 2019
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    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.

    Action

    A Stop Use Notification was sent to affected customers on December 19, 2018. This notification requested customers to return the device. The formal customer recall letter was sent on January 16, 2019.

    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