Events

Recall of Device Recall System,surgical,computer controlled instrument

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
    74188
  • Event Risk Class
    Class 2
  • Event Number
    Z-1837-2016
  • Event Initiated Date
    2016-05-09
  • Event Date Posted
    2016-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146670
  • 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
    Potential for particulates in insufflation stopcocks on the da vinci xi surgical system cannula seals. the particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
  • Action
    Upon discovery of the issue, Intuitive sent Urgent Product Safety Notices to all customers by e-mail to initially alert them of the situation. This will be followed by a formal letter that is scheduled to arrive on May 23, 2016. Both notification request that users Do NOT use the da Vinci Xi 5 mm8 mm Universal Cannula Seal or the da Vinci Xi 12 mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during intracardiac procedures.

Device

Device Recall System,surgical,computer controlled instrument
  • Model / Serial
    All lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Product Description
    SEAL,IS4000 PORTS,12MM&STAPLER;,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.
  • 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