| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00360-1 |
| Product Name/Description |
Thermablate Endometrial Ablation System (EAS)
Thermablate Treatment Control Unit Kit
Product Code: I-22001
Thermablate Disposable Cartridge
Product Code: 1-21004
All Lot Numbers
ARTG Number: 186661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
03 9822 5911 - Gytech Pty Ltd |