BEUDAMED
    FDA Enforcement Class II Terminated

    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

    Recall: Z-1105-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1105-2020
    Event ID
    83994
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 4, 2018
    Classification Date
    February 6, 2020
    Termination Date
    August 24, 2022
    Address
    1266 Kifer Rd Bldg 101, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

    Reason

    This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

    Code Info

    Serial Number/Manufacturing Lot: N11181003, N11181004

    Distribution

    US National Distribution Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming OUS:None

    Quantity

    286 Monopolar curved scissors