Events

Recall of Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)

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-00583-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00583-2
  • 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 manufacturer has received a small number of customer complaints regarding damaged 5mm cannula which could lead to difficulty inserting or utilising 5mm surgical instruments. using a damaged or bent cannula can result in the loss of smooth instrument motion and/or particles of instrument shaft material being generated, which may drop into the patient.
  • Action
    Device Technologies is updating the current instructions for use with a modified inspection process for the identification of damaged or bent cannula using an obturator which will be provided to users.

Device

Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)
  • Model / Serial
    Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)5mm CannulaProduct code: INS-4200115mm Flared CannulaProduct code: INS-420262ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd