Events

Alerta De Seguridad para PlasmaSORD

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Gyrus Medical Limited.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-02-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150213.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gyrus Medical PlasmaSORD
  • Manufacturer
    Gyrus Medical Limited

Manufacturer

Gyrus Medical Limited