Events

Alerta De Seguridad para Trade name: Force Argon II System Valleylab / Laparoscopic Electrode Valleylab Technical Name: High Frequency Surgical Equipment / Electrode ANVISA Registration Number: 10349000185/10349000216

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
    2127
  • Fecha
    2016-07-12
  • 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
    If you have the affected items in accordance with Attachment A of the Letter to Customer FA Valleylab, please follow the following recommendations: We request that you identify the affected products as per Appendix A and later segregate these items, which are out of use, for later collection that will be performed by Medtronic. Products that are out of use for which item and lot codes are affected must be returned as described in the "Required Actions" section below. If you have distributed the ValleyLab ™ Laparoscopy Electrodes listed in Appendix A, immediately forward the information in this letter to these recipients. All new item and affected item code products must be returned.
  • Causa
    Medtronic is voluntarily recalling specific item codes and production batches of covidien valleylab laparoscopy electrodes. this voluntary recall will be performed due to possible packaging compromise, resulting in a breach of the sterile barrier. using products with such defective packaging may increase the risk of infection. there are no reports of serious injuries associated with this problem.
  • Acción
    Field Action Code FA ValleyLab triggered under the responsibility of the company Auto Suture do Brasil Ltda. Company will make collection for later return to the manufacturer.

Device

Trade name: Force Argon II System Valleylab / Laparoscopic Electrode Valleylab Technical Name: Hi...

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