Australian Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning PlasmaSORD with product code 962000PK, manufactured by Gyrus Medical Limited.
Based on a concern raised in the United States 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 Instructions for Use (IFU) for the device.
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
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00112-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
13 February 2015