Events

Recall of da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

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-01067-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01067-1
  • 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
    The patient cart is a robotic platform used for da vinci surgery. during normal use the cart can be exposed to small amounts of fluids from the environment (during cleaning for example) without impairing function. improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers. during surgical procedures there is also a small risk that fluid can be transferred inside the patient cart, for example, biological or i.V. fluids. the system user manual at the time instructed the user to contact intuitive surgical in the cases where components came into contact with liquids. however, there was no specific warning about the consequences of exposure to liquids. this recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Action
    Device Technologies has installed a fluid ingress protection kit on all IS2000 and IS3000 systems.

Device

da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

Manufacturer

Device Technologies Australia Pty Ltd