Events

Recall of Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

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
    RC-2013-RN-01248-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01248-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Intuitive surgical has become aware that friction within certain patient side manipulators (ie, instrument arms) can interrupt smooth instrument motion. this interruption is felt by the surgeon as resistance in the movement of the mast. in this situation, the instrument can stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance. this resistance is most noticeable when moving the instrument at very slow speeds and during small movements of the masters. this system behaviours is not autonomous instrument motion. the variable function is immediately apparent to the surgeon, and they would exercise surgical judgment to continue use in only situations where the risk is low. however, they would not necessarily be anticipating an interruption of smooth instrument motion, so may not avoid all vulnerable structures.
  • Action
    Device Technologies is testing affected Patient Side Manipulators (instrument arms) and replacing or repairing instrument arms as required. Device Technologies in providing work around instructions for users to follow as an interim measure.

Device

Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactu...
  • Model / Serial
    Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd