Events

Recall of Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)

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-00390-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00390-1
  • 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 sterile adapter acts as an interface between the sterile surgical instruments and non-sterile system. intuitive surgical is undertaking market action to provide users of the da vinci s, si and si-e systems with additional information regarding sterile adapter engagement and instrument installation. although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments.
  • Action
    Device Technologies is providing their customers with further training to ensure the correct engagement of the sterile adaptor. Additional quick reference instructions will also be provided.

Device

Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)
  • Model / Serial
    Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)Model numbers: da Vinci S - IS2000da Vinci Si - IS3000da Vinci Si-e - IS3000Serial numbers: IS2000 IFU 550516-05; IS3000 IFU 550650-05
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd