Alerta De Seguridad para Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Ethicon Endo-Surgery.

¿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
    2012-08-06
  • Fecha de publicación del evento
    2012-08-06
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: ethicon endo-surgery proximate® pph hemorrhoidal circular stapler and accessories 33mm and proximate® hcs hemorrhoidal circular staple and accessories 33mm medical device manufacturer, ethicon endo-surgery, has initiated a global voluntary recall for specific production lots of proximate® pph hemorrhoidal circular stapler and accessories 33mm (product code pph03) and proximate® hcs hemorrhoidal circular stapler and accessories 33mm (product code pph01) due to difficulty in firing the device which may result in incomplete firing stroke that may lead to an incomplete staple formation. the manufacturer advised all users to discontinue use of affected products. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 6 august 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm
  • Manufacturer

Manufacturer