| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00112-1 |
| Product Name/Description |
PlasmaSORD
Product Code: 962000PK
ARTG Number: 141561 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Based on a concern raised in the US relating to the potential risk of transcoelomic spread of undiagnosed cancerous tissue with the use of morcellators in the treatment of uterine fibroids, the manufacturer has issued an updated IFU which has been included in this communication. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Olympus is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators.
The TGA has published information on the risks associated with power morcellators on the TGA website at:
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014
- https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 18/07/2016. |
| Contact Information |
1300 132 992 - Olympus Australia Pty Ltd |