Events

Recall of Intuitive Surgical da Vinci Patient Side Manipulators

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
    15753
  • Event Initiated Date
    2013-11-28
  • 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
    Manufacturer has become aware that friction within certain instrument arms can interrupt smooth instrument motion. this interruption is felt by by the surgeon as resistance in the movement of the master. in this situation the instrument can stall momentarily and then suddenly catch-up to the master psition id the surgeon pushes through the resistance. this resistance is most noticeable when moving the instruments at very slow speeds and during small movements of the masters. this system behaviour is not autonomous instrument motion.
  • Action
    Product to be modified

Device

Intuitive Surgical da Vinci Patient Side Manipulators
  • Model / Serial
    Model: da Vinci S, Si and Si-e Patient Side cart, Affected:
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc