Events

Recall of Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Gytech 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-2014-RN-00573-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00573-1
  • 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
    This action is undertaken to inform users of an update to the instructions for use (ifu) for the thermablate endometrial ablation system (eas). the ifu updates are in the following sections:1) directions for use / treatment - includes an additional precautionary step in the sequence of procedures just prior to inserting the thermablate catheter into the uterus to initiate treatment. the sequence now includes a requirement for a second sounding of the uterus just after dilation and before performing hysteroscopic examination of the uterus to confirm that perforation of the uterus or the creation of a false passage has not occurred during the dilation and soundings.2) contraindications – the current contraindication i.E., “a patient with lower segment c section scar that has a linear scar thickness of less than 1cm” is being amended to “a patient that has had three or more, lower segment c sections and where the linear scar thickness in those patients is less than 8mm”.
  • Action
    Customers are provided with the updated IFU along with the customer letter. This action has been closed-out on 11/02/2016.

Device

Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit
  • Model / Serial
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit KitProduct Code : I-22101 Thermablate Disposable Cartridge Product Code : I-21004ARTG number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd