Alerta De Seguridad para Trade name: Surgical Focus Vol. Technical Name: Surgical Focus. ANVISA Registration Number: 80259110132. Hazard Class: I. Model Affected: Surgical Focus Volista Access .. Serial Numbers Affected: 36008; 38005; 38033; 38039; 500153; 35000; 36016; 38008; 38013; 38032; 38034; 38037; 500000; 500001; 500001; 500002; 500002; 500003; 500004; 500005; 500006; 500007; 500008; 500009; 500010; 500011; 500012; 500013; 500014; 500015; 500016; 1002; 36031; 36032; 36033; 36034; 36035; 36036; 36037; 36038; 36039; 36040; 38006; 38011; 38030; 38035; 38038; 38058; 38059; 38060; 38061; 38063; 38064; 38029; 38033; 38036; 500133; 36017; 36018; 38035; 38007; 38010; 38033; 38034; 500155; 31000; 38009; 38012; 38031; 38035; 38038; 20509; 500154

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Maquet do Brasil Equipamentos Médicos Ltda; MAQUET SAS.

¿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
    This MAQUET VOLISTA Field Notification needs to be distributed to those individuals who need to be aware within their organization - or any organization to which the potentially affected devices have been transferred. Maintain awareness of this notification and the resulting action for the appropriate period of use of the device to ensure the effectiveness of corrective action. In cases where you as a customer choose not to comply with the corrective action requirements described above, MAQUET can not accept any responsibility for problems related to safety or legal liabilities caused by the failure to respond to the Field Safety Notice. 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: 08/01/2018 - Date of notification notice to Anvisa: 01/28/2018 The company that owns the affected product is responsible for contacting its customers in due time. 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
    This action consists of replacing the central support ring of the mitt. we have received complaints that the central handle support detaches easily from the dome during use. we determined that the root cause of this malfunction is the excessive tightening of the bolts during the assembly of the handle support, resulting in the loosening of the rivets and the detachment of the central support ring from the handle. during manipulation, the handle support can come off completely from the focus point if all three rivets loosen simultaneously. in this case, although the handle remains in the user's hand, small amounts of particles can be generated from the plastic support ring. from our clinical evaluation, it has been concluded that there is a remote chance that this problem can cause postoperative infection, foreign body granuloma or allergic reactions, if the particles fall into the patient's wound or in sterile equipment. the problem was solved in production by a change in the design of the rivets (modification of the shape and over mold with the handle support ring). for units manufactured prior to the application of the change in production, we see the problem as a potential long-term hazard and we want to prevent the occurrence of any event related to our customers. this action consists in replacing the existing central support rings with the new design.
  • Acción
    Field Action Code MAS-2017-006IU triggered under the responsibility of Maquet do Brasil Equipamentos Médicos Ltda. Will make correction in the field.


  • Empresa matriz del fabricante (2017)
  • Source