Events

Recall of Thermablate Endometrial Ablation System (EAS)

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-2015-RN-00360-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00360-1
  • 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 instructions for use (ifu) of the thermablate endometrial ablation system (eas) is updated due to four case reports of uterine perforation. there is an increased risk of patient injury (including damage to non-targeted tissue) if both thermablate eas procedure and hysteroscopic tubal occlusion/sterilisation are performed on the same day.
  • Action
    Additional warning is being added to the IFU as follows : "Do not perform same day Thermablate EAS procedure and hysteroscopic tubal occlusion/sterilization. Thermablate EAS procedure can be safely and effectively performed with nickel titanium inserts in place, however the procedure should only be performed after the 3 month tubal occlusion confirmation test." Gytech Pty Ltd is informing the customers of the additional warning as updated in the Instructions For Use (IFU). The IFU document (Ref. No: LS2101, Rev C) currently supplied with the Disposable Cartridge already includes these changes. This action has been closed-out on 5/08/2016.

Device

Thermablate Endometrial Ablation System (EAS)
  • Model / Serial
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit Product Code: I-22001Thermablate Disposable Cartridge Product Code: 1-21004All Lot NumbersARTG Number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd