Alerta De Seguridad para da Vinci Xi 5 mm-8 mm Universal Seal and da Vinci Xi 12 mm & Stapler Universal Seal

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Intuitive Surgical.

¿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
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: intuitive surgical da vinci xi 5 mm-8 mm universal seal and da vinci xi 12 mm & stapler universal seal medical device manufacturer, intuitive surgical, has issued a medical device safety alert concerning its da vinci xi 5 mm-8 mm universal seal (pn 470361-05 and 470361-06) and da vinci xi 12 mm & stapler universal seal (pn 470380-05 and 470380-06). the manufacturer is initiating a warning regarding use of the abovementioned products in intra-cardiac procedures. the manufacturer identified particulate during quality inspections of the insufflation stopcock on the da vinci xi 5 mm-8 mm universal seal. the particulate has the potential to be introduced into the cannula lumen when insufflation is connected. although there have been no injuries identified related to this issue, the manufacturer is initiating this warning for use in intra-cardiac procedures due to risk of foreign body embolism should particulates remain undetected and unintentionally left inside the heart. during abdominopelvic and thoracic surgery, if the potential particulate is undetected and unintentionally left behind, health risk is minimal due to the bio-inert properties of the high density polyethylene (hdpe) particulate, its small size and the benign particulate geometry. the potential particulate is no larger than 1/8" in length with no sharp edges. it is composed of hdpe, a bio-inert material. hdpe has been used as bone and cartilage implants since the 1940s with more than 30 years of follow-up results showing favorable response to hdpe implants. hdpe is non-ferromagnetic and, as such, an unrecovered particulate will not cause the patient harm if exposed to mri. the following instructions are provided to the affected users: until this issue is resolved, as an alternative to insufflation through the da vinci xi 5 mm-8 mm universal seal (pn 470361) or the 12 mm & stapler universal seal (pn 470380) during intra-cardiac procedures, use an angio-catheter, or veress needle, through the chest wall for initial access and to maintain insufflation throughout the procedure. do not use the da vinci xi 5 mm-8 mm universal seal or the 12 mm & stapler universal seal for insufflation, or open the stopcock during the procedure. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 may 2016.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Intuitive Surgical da Vinci Xi 5 mm-8 mm Universal Seal and da Vinci Xi 12 mm & Stapler Universal Seal
  • Manufacturer