Events

Alerta De Seguridad para Duet TRS™ Universal Straight and Articulating Single Use Loading Units

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

¿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
    2012-01-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120116.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
    Field safety notice: recall of covidien duet trs™ universal straight and articulating single use loading units medical device manufacturer, covidien, is conducting a voluntary recall for all production lots of duet trs™ universal straight and articulating single use loading units with respect to the use of this product family in the thoracic cavity. covidien has received reports of 3 deaths and 13 serious injuries following the application of duet trs™ loading units in the thoracic cavity. covidien concluded that duet trs™ loading units has the potential to injure adjacent anatomical structures within the thorax which may result in life threatening post-operative complications. there have been no reports of adverse event in hong kong. the manufacturer advised that users should not use the device in thoracic surgery in both adult and paediatric populations. users may continue to use the device in other applications. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Duet TRS™ Universal Straight and Articulating Single Use Loading Units
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Recall of Covidien Duet TRS™ Universal Straight and Articulating Single Use Loading Units
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 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