Events

Recall of da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mm

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-2016-RN-00701-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00701-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, is issuing this warning notice in relation to the use of da vinci xi 5mm-8mm universal cannula seal and da vinci xi 12mm & stapler universal cannula seal in all surgical procedures.During internal inspections, intuitive surgical has identified particulate in the insufflation stopcocks on the da vinci xi 5mm-8mm universal cannula seal. the particulate generated from the seal material has the potential to be introduced into the cannula lumen when insufflation is connected. there have been no injuries reported related to this issue.
  • Action
    Users are advised to not use the da Vinci Xi 5mm-8mm Universal Cannula Seal or the da Vinci Xi 12mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during all types of surgical procedures until this issue is resolved. It is recommended to use an alternative device such as an angio-catheter, Veress needle or laparoscopic trocar for initial access and to maintain insufflation throughout all procedures as an alternative to insufflation through the da Vinci Xi 5mm-8mm Universal Cannula Seal (INS-470361) or the da Vinci Xi 12mm & Stapler Universal Cannula Seal (INS-470380). This action has been closed-out on 20/02/2017.

Device

da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealU...
  • Model / Serial
    da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mmPart Number: INS-740361 Stapler Universal Cannula Seal, 12mm & StaplerPart Number: INS-470380ARTG Number: 181744
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd