Events

Alerta De Seguridad para Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer

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
    2012-12-04
  • Fecha de publicación del evento
    2012-12-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121204.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: ethicon endo-surgery enseal g2 curved and straight tissue sealer the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning enseal g2 curved and straight tissue sealer, manufactured by ethicon endo-surgery (ees). the affected products could be identified by the following product codes: nslg2c14, nslg2c25, nslg2c35, nslg2c45, nslg2s14, nslg2s25, nslg2s35, nslg2s45. all lot numbers with expiration date from october 2013 through september 2017 are impacted. according to the manufacturer, there is a potential for self-activation while the device is in use, which could result in injury to patients or users (thermal damage). to date, the manufacturer has not received any reports of patient or user injuries. the manufacturer advises all affected users to stop immediately the use of ees enseal g2 curved and straight tissue sealer. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con208680 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 december 2012.

Device

Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery