Events

Recall of Device Recall Intuitive da Vinci S

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
    46160
  • Event Risk Class
    Class 2
  • Event Number
    Z-0669-2008
  • Event Initiated Date
    2007-11-19
  • Event Date Posted
    2008-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66936
  • 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
    Cannula - Product Code NAY
  • Reason
    Sharp edges: the 5mm cannula may have a sharp edge on the inner diameter of the cannula. the defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
  • Action
    On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Intuitive da Vinci S
  • Model / Serial
    Lot Numbers Affected:  SA070902, SA071101, and SA071401
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
  • Product Description
    Intuitive brand da Vinci S, 5 mm Instrument Cannula || Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, || Sunnyvale, CA
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

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