Events

Recall of Device Recall da Vinci Xi 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
    77389
  • Event Risk Class
    Class 2
  • Event Number
    Z-2630-2017
  • Event Initiated Date
    2017-06-01
  • Event Date Posted
    2017-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155915
  • 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
    Da vinci xi(r) surgical system patient side carts (psc) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
  • Action
    Intuitive Surgical sent an Field Safety Notice letter dated June 1, 2017 to customers. The letter was sent electronically via through our da Vinci customer portal via email to the affected sites on June 1, 2017. Letters are sent to the da Vinci Coordinator, Recall Coordinator and/or Risk Management. The customer will receive a hard copy of this letter on June 6, 2017 via Fed Ex. The letter identified the affected product, problem and actions to be taken. For questions contact your Clinical Sales Representative.

Device

Device Recall da Vinci Xi Surgical System
  • Model / Serial
    Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan
  • Product Description
    da Vinci Xi Surgical System || Product Usage: || The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.
  • 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