Alerta De Seguridad para ENDOPROTYPE ANACONDA. Registration ANVISA n ° 80012280090. Models at Risk: Anaconda One-Lok Bifurcated Body and Anaconda Bifurcated Body. Lots under risk: OLB21; OLB23; OLB25; OLB28; OLB30; OLB32; OLB34; B19 * 01; B19 * 02; B21 * 01; B21 * 02; B23 * 01; B23 * 02; B25 * 01; B25 * 02; B25 * 01; B25 * 02; B30 * 01; B30 * 02; B32 * 01; B32 * 02; B34 * 01; B34 * 02 (all batches).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo Medical do Brasil Ltda.; Vascutek Limited Inc..

¿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
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    According to information submitted by Terumo, the manufacturer of the products (Vascutek Ltd) received 3 complaints (with an occurrence rate of 0.1%) reporting anaconda body release system wire fracture. Two of these three incidents resulted in conversion to open chest surgery. Vascutek ltd has initiated a voluntary recall of all anaconda bodies, with root cause identification and implementation of corrective actions ongoing. Voluntary recollection aims to reduce potential risks to the patient associated with wire fracture and the possibility of conversion to open chest surgery. A clinical evaluation was performed for the three adverse events and the high patient safety risk was confirmed by the conversion of the previously minimally invasive open chest surgery. Although the frequency of occurrence is low, the fact that the problem can not be detected during the manufacturing or before the procedure is performed, supports that the recommended action is the collection of the bodies of the market. Users are advised to discontinue use of this product immediately, to block and segregate existing inventory and to return it to terumo medical do brasil ltda. The company will return the items to the manufacturer. Prosthetics already implanted are not affected by this recall, since the problem is restricted to the delivery system. The retreat does not extend to the iliac branch anaconda, broad iliac branch or aortic extension. For more detailed information, consult the Alert Message of the company at: #### Update on 08/27/2014: the field action was completed by the company on 02/11/2014, as informed to Anvisa (08/13/2014). 413 units were collected from a total of 910 units at risk in Brazil.
  • Causa
    Possibility of fracture of the wire of the system of liberation of the body of the device anaconda.
  • Acción
    Terumo is collecting the products at risk. Discontinue use of the product immediately. Identify, lock and segregate existing inventory to avoid inadvertent use.