Events

Alerta De Seguridad para LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier

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
    2013-05-07
  • Fecha de publicación del evento
    2013-05-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130507.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 ligaclip 10mm m/l endoscopic rotating multiple clip applier the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning ligaclip 10mm m/l endoscopic rotating multiple clip applier manufactured by ethicon endo-surgery, llc (a johnson & johnson company). the affected code number is er320 (with expiration dates from november 2016 to march 2018). the manufacturer has identified potential clip formation and feeding issues, which may result in improper clip formation and insufficient occlusion of the vessel or other structure. product recall of affected units is on-going. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00396-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 may 2013.

Device

LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery