Events

Alerta De Seguridad para Product: ULTRASONIC SYSTEM CUSA. Registration: 10099430147. CEM Nosecones (C6623 or C6626) with CUSA Excel / Excel + Ultrasonic Aspirator

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por INTEGRA LIFESCIENCE LIMITED; INTEGRA LIFESCIENCES CORPORATION.

¿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
    1227
  • Fecha
    2013-01-17
  • 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
    The company that holds the registration in Brazil has notified this ANVISA.
  • Causa
    Since 2009, integra has received a small number of cusa tip breaking claims. none of these claims resulted in patient harm or any adverse health consequences. research has been carried out and it has been identified that these tips are used in some specific circumstances with nosecone cem and there is a potential chance of wear of the cusa tip. this potential wear can lead to tip breakage. specifically, the wear potential of cusa occurs during the emc operation specifically at the contact between the tip side and the fabric, when this contact should occur only between the tip and the fabric.
  • Acción
    The company has sent a letter (Medical Device Safety Notice) (Annex) to its customers informing them of the problem and is in the process of reviewing the Instructions for Use of the Product (Annex). http://en.wikipedia.org/w/eng/index.php/

Device

Product: ULTRASONIC SYSTEM CUSA. Registration: 10099430147. CEM Nosecones (C6623 or C6626) with C...

Manufacturer

INTEGRA LIFESCIENCE LIMITED; INTEGRA LIFESCIENCES CORPORATION