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
    2012-08-24
  • Fecha de publicación del evento
    2012-08-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120824a.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 duet™ trs universal straight and articulating single use loading units medical device manufacturer, covidien, is conducting a voluntary recall of all production lots for the duet trs™ universal straight and articulating single use loading units (sulu). in addition, the company has discontinued manufacturing the duet trs™ universal straight and articulating sulu. serious injuries and/or deaths could occur due to the failure mode associated with this recall. covidien has received one report that links the duet trs™ tissue reinforcement material to a postoperative injury after abdominal surgery. the company has concluded that duet trs™ may have the potential to injure adjacent anatomical structures, which may result in life threatening postoperative complications. specifically, exposed edges of tissue reinforcement material may cause lacerations, punctures or trauma to adjacent anatomical structures resulting in pain, bleeding or other post-operative complications. this is in addition to the recall conducted in january of 2012 which contra-indicated the use of duet trs™ for thoracic surgery. at that time, covidien received reports of thirteen serious injuries and three deaths, following the application of duet trs™ in the thoracic cavity. 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. posted on 24 august 2012.

Device

DUET™ TRS Universal Straight and Articulating Single Use Loading Units
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: 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