Events

Recall of Device Recall Da Vinci S 8mm Instrument Cannula

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
    46890
  • Event Risk Class
    Class 2
  • Event Number
    Z-1348-2008
  • Event Initiated Date
    2008-01-04
  • Event Date Posted
    2008-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68404
  • 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
    Computer Controlled Instrument - Product Code NAY
  • Reason
    (1) incorrect dimension on luer on smoke evacuation cannulae not allowing for secure attachment function. (2) incorrect labeling. external labeling lot number differs from lot number etched on the cannula.
  • Action
    On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.

Device

Device Recall Da Vinci S 8mm Instrument Cannula
  • Model / Serial
    Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; || Model IS2000, Part Numbers: 400254-01, 400255-01; || Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. || Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

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