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
    69638
  • Event Risk Class
    Class 2
  • Event Number
    Z-0448-2015
  • Event Initiated Date
    2014-11-03
  • Event Date Posted
    2014-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131248
  • 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
    Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.
  • Action
    Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.

Device

Device Recall da Vinci Xi Surgical System
  • Model / Serial
    Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
  • Product Description
    8MM, TIP-UP FENESTRATED GRASPER; || Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • 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