Events

Recall of Minop Invent 30 degrees Trocar D 8.3mm L 150mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun 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-2017-RN-00371-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00371-1
  • 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
    An issue has been identified whereby the insulation of an electrode has been damaged intra-operatively when it is pulled out of the minop invent trocar. subsequent investigation has shown some burrs at the distal working end of the trocar.
  • Action
    B. Braun is advising customers to complete and return the Reply Form in order for their affected stock to be collected and replaced.

Device

Minop Invent 30 degrees Trocar D 8.3mm L 150mm
  • Model / Serial
    Minop Invent 30 degrees Trocar D 8.3mm L 150mmArticle Code: FH620RARTG Number: 106672
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd