Events

Safety Alert for PlasmaSORD

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Gyrus Medical Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-02-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150213.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: gyrus medical plasmasord 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.

Device

PlasmaSORD
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Gyrus Medical PlasmaSORD
  • Manufacturer
    Gyrus Medical Limited

Manufacturer

Gyrus Medical Limited