Events

Recall of 8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)

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-00539-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00539-1
  • 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
    The manufacturer has received customer complaints regarding dislodged cautery plug inserts which prevents a bipolar cautery cable from being properly connected to the instrument, resulting in loss of cautery function of the bipolar instrument. the dislodged cautery plug insert most commonlyoccurs prior to the commencement of a procedure, but may be noticed when connecting or disconnecting the bipolar cautery cable during the procedure.
  • Action
    Customers are asked quarantine any affected stock and return them.

Device

8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)
  • Model / Serial
    8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200) Product code: INS-400172Lot numbers: M10120815, M10120817, M10120831, M10120913, M10120918, M10121008, M10121024, M10121120, M10121123, M10121203, M10121210, M10121215, M10130220, M10130222, M10130311, M10130315, M10130411ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd