Events

Recall of da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systems

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-2014-RN-01310-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01310-1
  • 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 received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in labelling for the da vinci s, si or si-e surgical system, instruments and accessories.Intuitive surgical is initiating a correction related to labelling updates to distributed user manuals, instructions for use (ifu), quick reference guides (qrg)and the natural rubber latex qrg as well as an instrument release kit (irk) for use with da vinci surgical systems, instruments and accessories. the labelling updates have been implemented to incorporate user feedback not previously addressed.
  • Action
    Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016.

Device

da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vi...
  • Model / Serial
    da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systemsAll Serial Numbers are affected Model Numbers: IS1200, IS2000, IS3000 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd