| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00573-1 |
| Product Name/Description |
Thermablate Endometrial Ablation System (EAS)
Thermablate Treatment Control Unit Kit
Product Code : I-22101
Thermablate Disposable Cartridge
Product Code : I-21004
ARTG number: 186661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
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” |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are provided with the updated IFU along with the customer letter. This action has been closed-out on 11/02/2016. |
| Contact Information |
03 9822 5911 - Gytech |