Events

Alerta De Seguridad para SURGICAL ROBOT SURGICAL SYSTEM, Single-Site Maryland Dissector; Single-Site Medium-Large Clip Applier; Single-Site Cadiere Forceps; Single-Site Needle Driver; Single-Site Fundus Grasper; Single-Site Crocodile Grasper; Single-Site Maryland Bipolar Forceps; Single-Site Curved Needle Driver; Single-Site Fenestrated Bipolar Forceps. Models: 428050-12, -13, -14; 428053-12, -15; 428055-12, -13; 428056-12, -13; 428058-12, -13; 428059-12, -13; 428080-04, -05; 428088-12, -13; 428093-12, -13. risk class III.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por H. Strattner & Cia 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
    1718
  • Fecha
    2015-10-20
  • 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
    According to the manufacturer the alert informs that in identifying the failure in the mentioned items, the customer should contact the company so that the material is replaced and the defective unit will be sent to the manufacturer.
  • Causa
    The instrument may not open after being fixed to a tissue, causing the user to use a method indicated to open the jaw of the instrument, releasing the trapped tissue.
  • Acción
    Alerts users to follow the manufacturer's recommendations if the problem is identified. When the material presents the problem, the company must be informed so that the material is removed within 48 hours and replaced with a new unit.

Device

SURGICAL ROBOT SURGICAL SYSTEM, Single-Site Maryland Dissector; Single-Site Medium-Large Clip App...

Manufacturer

H. Strattner & Cia Ltda; Intuitive Surgical, INC.
  • Source
    ANVSANVISA