Events

Recall of Device Recall da Vinci S and Si Surgical 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
    71285
  • Event Risk Class
    Class 2
  • Event Number
    Z-1812-2015
  • Event Initiated Date
    2015-05-21
  • Event Date Posted
    2015-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137239
  • 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
    The coating of the 5 mm thoracic grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
  • Action
    Urgent Medical Device Recall letters were sent to all consignees on May 21, 2015. The letter describes the affected product and issue involved. Additionally, the risk to health, as well as the actions to be taken were also discussed in the letter. Customers are to ensure that all affected personnel were informed of the notice. All affected product are to be identified and returned by contacting Customer Service for a RMA. The Acknowledgment Form is to be completed and returned using the instructions provided. If further information or support concerning this recall is needed, customers are to contact their local Clinical Sales Representative or Intuitive Surgical Customer Service.

Device

Device Recall da Vinci S and Si Surgical System
  • Model / Serial
    version 420343-01 and 420323-02, all lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Product Description
    Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. || Intended for endoscopic manipulation of tissue, including grasping.
  • 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