Events

Recall of Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

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-00759-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00759-1
  • 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 inc. have become aware of the larger clip applier instrument jamming or feeling friction during insertion into the 8mm cannula or into certain cannula reducer accessories. no adverse events have been reported due to this issue. if an instrument gets jammed in the cannula or reducer accessory during insertion this may prevent or delay the use of the instrument. as the type of clip applied by the clip applier is used to occlude controlled vessels rather than during episodes of active bleeding, a delay in clip application will have no immediate or long term health consequences for the patient.
  • Action
    A software update has been developed to correct the issue. The product may continue to be used while software upgrades are being made in the field. The software upgrade will reduce the degree to which the jaws on the Large Clip Applier Instrument open during insertion and will eliminate the occurrence of jamming.

Device

Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

Manufacturer

Device Technologies Australia Pty Ltd