Events

Alerta De Seguridad para FAMILY TROCATER ACCESS - Technical Name: Trocartes - Registry 80251140010 - Risk Class II (Medium Risk) - Model: AI1950 - Lots: 586, 587 and 606.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AMERICAN INSTRUMENTS.

¿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
    1661
  • Fecha
    2015-08-17
  • 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 company, "There is a remote probability of a reversible adverse event during withdrawal of the stainless steel cannula from the abdominal cavity. The crushed plastic part (concave head) detaches itself from the cannula and the surgeon, when attempting to remove the mandrel from the trocar cannula, is unable to withdraw fully and hand contact is necessary in the part remaining in the cavity.
  • Causa
    Traced head of the trocater discharge of the inox canal (mandril) impossibilitando the use during surgical procedure. after investigation and analysis of the materials, a nonconformity with respect to the reported failure was found and concluded that the propagation of process tolerance uncertainties resulted in an excessive residual stress for the material. these tolerances have been adjusted so as to reduce this voltage and prevent premature breaking of the component.
  • Acción
    The company will collect the products at risk, while recommending not to use material from the problem lots. Replacement of defective material by new batch. (Letter to customers in ANNEX Code AI1950

Device

FAMILY TROCATER ACCESS - Technical Name: Trocartes - Registry 80251140010 - Risk Class II (Medium...

Manufacturer

AMERICAN INSTRUMENTS
  • Source
    ANVSANVISA