Events

Recall of Device Recall 30 deg, 8mm Endoscope, IS4000

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
    72776
  • Event Risk Class
    Class 2
  • Event Number
    Z-0653-2016
  • Event Initiated Date
    2015-11-23
  • Event Date Posted
    2016-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142188
  • 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
    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.
  • Action
    Intuitive Surgical sent an Urgent Medical Device Correction letter to affected customers on December 4, 2015,. Letters explained the issue and provided action to follow to prevent the issue. Customers were instructed to do the following: Distribute a copy of this letter to all da Vinci Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 5. Retain a copy of this letter and the Acknowledgement Form for your files. If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)

Device

Device Recall 30 deg, 8mm Endoscope, IS4000
  • Model / Serial
    Model numbers: 470027-34, 470027-40, 470027-41. All lots.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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. .
  • Product 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.
  • 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