Events

Recall of Device Recall da Vinci Si 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
    70181
  • Event Risk Class
    Class 2
  • Event Number
    Z-1048-2015
  • Event Initiated Date
    2015-01-15
  • Event Date Posted
    2015-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132453
  • 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
    The wall chart has been updated because it was noted that wall chart (pn 551524-03 rev a) was inconsistent with the user manual adendum (pn 550986-07_b) with regards to neceassary sterilization dry time.
  • Action
    Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on the updated instructions for use. A Clinical Sales Representative or Intuitive Surgical Customer Service at 1-800-876-1310, should be contacted if further information or support is needed concerning the recall notification.

Device

Device Recall da Vinci Si Surgical System
  • Model / Serial
    PN 410298-05, -06, -07, -08, -09
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. || 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