BEUDAMED
    FDA Enforcement Class II Terminated

    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

    Recall: Z-2348-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2348-2016
    Event ID
    74705
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    July 14, 2016
    Classification Date
    August 5, 2016
    Termination Date
    January 3, 2017
    Address
    1266 Kifer Rd Bldg 100, Sunnyvale, CA, 94086-5304, United States

    Description

    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

    Reason

    An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend

    Code Info

    All

    Distribution

    US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.

    Quantity

    2065 total