Events

Recall of Device Recall Patient Cart used in conjunction with the da Vinci S surgical and SI System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66526
  • Event Risk Class
    Class 2
  • Event Number
    Z-0139-2014
  • Event Initiated Date
    2012-11-30
  • Event Date Posted
    2013-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122550
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    Increased number of complaints regarding fluid entering the patient card base of the da vinci s and si systems.
  • Action
    Intuitive Surgical Inc sent an Product Notification to all affected customers via email on November 30, 2012. E-mail notifications advised users of an addendum to the User Manual for Covering the Patient Cart column that provided a recommended method for covering the da Vinci patient cart column to prevent splashing on the cart during a procedure. The addendum was attached to the e-mail and is available online. If you have any questions, please contact Customer Service at 1-800-876-1310. Outside the United States call +41 21 821 2020 or +800.0821.2020

Device

Device Recall Patient Cart used in conjunction with the da Vinci S surgical and SI System
  • Model / Serial
    Model IS2000 and IS 3000
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Puerto Rico and the countries of Australia, Austria, Argentina, Belgium, Bulgaria, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israel, Japan, Kuwait, Mexico, Netherlands, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay and Venezuela.
  • Product Description
    Patient Cart used in conjunction with the da Vinci S surgical and SI System. || Intuitive Surgical || 1266 Kifer Road || Sunnyvale, CA 94086 || The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA