Events

Recall of Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

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-2015-RN-01110-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01110-1
  • 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
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in: 1. a break in the roll gear and/or instrument shaft 2. damage to the push/pull mechanism that controls grip opening and closingif a da vinci si single-site instrument grip cannot be released normally or by opening the masters or the instrument release kit (irk), the surgeon may need to excise tissue in order to extract the instrument.
  • Action
    The customer is to inspect and remove any instrument that shows signs of damage. If the instrument grips remain closed on tissue during surgery and the IRK cannot be used, the surgeon is to follow the instructions in the User Manual addendum to manually release the grip. The sponsor is to arrange the return of the product and credit. This action has been closed-out on 18/04/2017.

Device

Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

Manufacturer

Device Technologies Australia Pty Ltd