Events

Alerta De Seguridad para Valleylab Cool-Tip RF electrode and auxiliaries - MS Registry: 10349000258. Affected lots - see annex. http://en.wikipedia.org/w/eng/wiki/index.php

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AUTO SUTURE DO BRASIL LTDA.

¿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
    1161
  • Fecha
    2012-08-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Anvisa is following this action.
  • Causa
    Potential degradation hazard of localized foil over dgp-hp rfa high-power single-use grounding plates. this degradation of the metal foil may result in an electrical disconnection and an undesirable thermal profile during use, which may result in burns to the patient at the site of the plaque.
  • Acción
    (1). Immediately quarantine the device and discontinue use. (2). Immediately inform all users of the DGPHP RFA High Power single use grounding plates and the Cool-tip RF Electrode Kit on this Recall. (3). Fill in and Sign the Customer Return Form below, REGARDLESS OF HAVING OR NOT the affected product at your location and send by e-mail to atendimento.brasil@covidien.com or by Fax: 0800- 17-80-17. (4). If you do not have affected lots units in your inventory, simply send the Customer Return Form indicating that you have zero (0) units. (5). If you have affected lots units, please return the affected product as follows: (a). Customers who purchased the product directly from Auto Suture do Brasil Ltda. Please fill in the form and send by e-mail: atendimento.brasil@covidien.com or Fax: 0800- 17-80-17. Upon receipt of your form, Auto Suture Customer Service will coordinate the collection and will bear the costs related to the freight. (B). If you purchased the product from a distributor, please complete the form and contact your Distributor directly. The completed form and all affected units must be returned through the Distributor. See attached Letter to the Client. http://en.wikipedia.org/w/index.php?title

Device

Valleylab Cool-Tip RF electrode and auxiliaries - MS Registry: 10349000258. Affected lots - see a...

Manufacturer

AUTO SUTURE DO BRASIL LTDA
  • 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
    ANVSANVISA