Alerta De Seguridad para Trade name: Da Vinci Xi English SRK. Technical Name: System for Endoscopic Surgery. ANVISA registration number: 81166920001. Risk class: III. Model Affected: 381395-01. Serial numbers affected: SK 1226; SK 1304; SK 1306

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Intutive Surgical Brasil Importação e Comércio de Equipamentos Cirúrgicos Ltda.; Intuitive Surgical, 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
  • 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
    In the scenario where you need to use the SRK, you must follow the instructions in the Stapler EndoWrist da Vinci Xi Instruments and Accessories User Manual that will be sent to the customers. In case of SRK tool breakage, the user must follow the instructions for using the Instrument Release Kit (IRK) tool to complete the opening of the stapler (loosening), and then return the SRK to Intuitive Surgical through the RMA (Return Material Authorization) process. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 10/08/2017 - Date of notification notice to Anvisa: 09/09/2017 The company holding the record of the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Intuitive surgical has received complaints regarding the breakdown of the davin xi® endowrist® stapler release kit (srk) tool during use. the purpose of this communication is to emphasize the need to use the srk correctly and provide additional instructions for scenarios in which the srk tool is damaged.
  • Acción
    Field Action Code ISIFA2017-02-C triggered under the responsibility of the company Intutive Surgical Brazil Importação e Comércio de Equipamentos Cirúrgicos Ltda. Emphasize information already provided in the instructions for use.