BEUDAMED
    FDA Enforcement Class II Terminated

    30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.

    Recall: Z-0653-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0653-2016
    Event ID
    72776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    November 23, 2015
    Classification Date
    January 14, 2016
    Termination Date
    April 5, 2016
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart touchscreen. Endoscopes are available with either a 0 degree or 30 degree tips.

    Reason

    This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs customers of scenarios that may result in unintended patient harm due to capacitive coupling from monopolar energy sources.

    Code Info

    Model numbers: 470027-34, 470027-40, 470027-41. All lots.

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela. .

    Quantity

    2624 total all models