Events

Retiro De Equipo (Recall) de CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por OLYMPUS CANADA 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
    Recall
  • ID del evento
    32993
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • 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
    On april 4 2014 a communication from the osta us distributor drew attention to the fact that part 000878-4 falope-ring dilator was inadvertently made available through the order system to customers and osta was shipping this item to our distributors in a non-sterile state. this item is normally only intended for use as a component provided with the falope ring band frb- 30 kits. the frb-30 kits including this component are sold sterile. this item is a dilator intended to assist placement of the falope band on the applicator. it contacts the sterile falope ring band as the band is loaded onto a reusable applicator and just prior to the band's implantation in the patient. as such it must be sterile in order to avoid the possibility of contaminating the falope ring band prior to use. no complaints related to these items have been received.

Device

CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM
  • Modelo / Serial
    Model Catalog: 000878-4 (Lot serial: N/A)
  • Descripción del producto
    GYRUS ACMI FALOPE-RING DILATOR
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.
  • Dirección del fabricante
    RICHMOND HILL
  • Empresa matriz del fabricante (2017)
    Olympus Corporation
  • Source
    HC