Events

Recall of Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)

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-01044-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01044-1
  • 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, intuitive surgical inc, is informing customers that the incorrect version of the user manual associated with the single-site instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments.
  • Action
    Device Technologies is notifying their customers of the issue. A Device Technologies representative will contact each customer to organise the delivery of the correct User Manual. Customers are requested to discard the previous version once the new User Manual has been received. This action has been closed-out on 10/02/2016.

Device

Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device wi...
  • Model / Serial
    Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)Single-Site Bipolar MarylandProduct Code: INS-428080Single-Site Curved Needle DriveProduct Code: INS-428088ARTG Number: 132453, 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd