Events

Recall of Intuitive Surgical 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
    38312
  • Event Risk Class
    Class 2
  • Event Number
    Z-0258-2008
  • Event Initiated Date
    2007-04-13
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53388
  • 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
    Dissecting Forceps - Product Code NAY
  • Reason
    Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a cf symbol not their proper bf symbol on the instrument housing. (all instruments meeting the cf isolation requirements are suitable for direct cardiac application, while instruments meeting bf isolation requirements are not suitable for direct cardiac application).
  • Action
    On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.

Device

Intuitive Surgical EndoWrist
  • Model / Serial
    All instruments manufactured till 03/21/07
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)
  • Product Description
    Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, 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