Events

Recall of Device Recall Intuiitve Surgical da Vinci EndoWrist

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
    31360
  • Event Risk Class
    Class 2
  • Event Number
    Z-0723-05
  • Event Initiated Date
    2005-03-09
  • Event Date Posted
    2005-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37728
  • 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
    Scissors, General, Surgical - Product Code LRW
  • Reason
    Blades on the scissor may break and separate from the main unit as a result of corrosion damage.
  • Action
    The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.

Device

Device Recall Intuiitve Surgical da Vinci EndoWrist
  • Model / Serial
    FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
  • Product Description
    Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA