Events

Alerta De Seguridad para Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Covidien Private 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
    2013-02-08
  • Fecha de publicación del evento
    2013-02-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130208a.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: covidien endo gia autosuture universal loading unit 30mm-2.0mm medical device manufacturer, covidien private limited issued a medical device safety alert concerning endo gia autosuture universal loading unit 30mm-2.0mm. the affected product code is 030450 and the affected lot numbers are n2f0563lx, n2f0341lx, n2f0725lx and n2e0605lx. covidien has received one report of adverse event where a single use loading unit contained two staples loading in each cartridge pocket. this condition may result in difficulty firing and removing the device from the application site, which may require medical intervention. according to the manufacturer, no post-operative complications related to this condition have been reported. covidien recommended the affected users to: immediately quarantine and discontinue use of the affected devices immediately advise all covidien endo gia autosuture universal loading unit 30mm-2.0mm users of this recall return the affected products to your supplier the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 february 2013.

Device

Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Covidien Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm
  • Manufacturer
    Covidien Private Limited

Manufacturer

Covidien Private Limited
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH