Retiro De Equipo (Recall) de TIP COVER ACCESSORY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INTUITIVE SURGICAL INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    During the manufacturing process to package each tip cover each part is placed into the top open end of a rectangular pre-made pouch which is sealed along the sides and bottom edges. to seal the pouch containing the product the open end edge is clamped and sealed by applying heat and pressure creating a closed seal impressed with a thatched pattern. it has been found with a small number of the pouches manufactured when creating the closure the sealed edge was not uniform and pleats or creases were formed within the seal area of the pouch. of those non-uniform seals in a small percentage of these seals these pleats or creases may breach the seal barrier integrity.


  • Modelo / Serial
    Model Catalog: 400180 (Lot serial: Contact manufacturer.); Model Catalog: 400180 (Lot serial: >10 lot numbers.)
  • Descripción del producto
    8MM Tip Cover Accessory
  • Manufacturer