BEUDAMED
    FDA Enforcement Class II Terminated

    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

    Recall: Z-2380-2018 · Reported July 18, 2018

    Enforcement

    Recall Number
    Z-2380-2018
    Event ID
    80318
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 18, 2018
    Initiation Date
    April 23, 2018
    Classification Date
    July 6, 2018
    Termination Date
    July 15, 2020
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

    Reason

    Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

    Code Info

    UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020

    Distribution

    U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

    Quantity

    7337