Events

Recall of Intuitive surgical da Vinci S Surgical System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    20087
  • Event Initiated Date
    2016-05-13
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    It is detemined that microscopic metallic particulate can be generated during both robotic and non-robotic intra-cardiac surgery. the use of the da vinci instruments other that the cardiac probe grasper (eg large needle driver) to manipulate a cardiac cryoablation probe during da vinci cardiac surgery has been shown to increase the amount of microscopic metallic particulate.
  • Action
    Instructions for use to be updated

Device

Intuitive surgical da Vinci S Surgical System

Manufacturer

Intuitive Surgical Inc