Events

Retiro De Equipo (Recall) de SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VANTAGE ENDOSCOPY 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
    14774
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-01
  • 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
    The operation manuals containing reprocessing instructions have been updated to reflect newly validated manual cleaning and high-level disinfection procedures. given publicized reports of multi-drug resistant bacteria on certain duodenoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures and in an abundance of caution fujifilm has been working with the fda to validate revised reprocessing procedures that have been provided in the operation manuals. healthcare providers are being instructed to follow the exact instructions for reprocessing provided in the revised operation manuals in order to minimize the risk of disease transmission.

Device

SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
  • Modelo / Serial
    Model Catalog: ED-530XT (Lot serial: all)
  • Descripción del producto
    Fujifilm Duodenoscope
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

VANTAGE ENDOSCOPY INC.
  • Dirección del fabricante
    KITCHENER
  • Empresa matriz del fabricante (2017)
    Diploma Plc
  • Source
    HC