Events

Alerta De Seguridad para Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Instruments ANVISA Registration Number: 13000059001 Hazard Class: I Model Affected: 21-345

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; Covidien LLC.

¿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
    2121
  • Fecha
    2016-10-07
  • 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
    There is no need for action with the patient. Patients who have received treatment with a Clearify Endoscope Lens Defroster and Protector affected by this recall should continue to be monitored according to standard practice. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    The purpose of this is to communicate that medtronic is voluntarily recalling item codes and specific production batches from our clearify ™ display system. this voluntary recall is being performed due to the potential compromise of the packaging, which can result in a rupture of the sterile barrier. the use of products with this defect in the packaging may increase the risk of infection. there were no reports of serious injuries associated with this problem.
  • Acción
    Field Action Code FA Recall Clearify triggered under the responsibility of AUTO SUTURE DO BRASIL LTDA. Company will collect for later return to Medtronic Field Returns Department.

Device

Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Ins...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Covidien LLC
  • 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