Events

Retiro De Equipo (Recall) de Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia Pty Ltd.

¿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
    RC-2013-RN-01053-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01053-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Device technologies australia (dta) in conjunction with the manufacturer is informing users of an important change in the instructions for use (ifu) for the reliance endoscope processing system (eps) when processing specific fujinon g5 and g8 type flexible gi endoscopes. when set up as defined in the ifu the air pipe on specific fujinon endoscopes doesn’t receive forced flow during the processing cycle. a new steris flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for reliance eps processing of any impacted fujinon devices. a new “quick reference guide” has been developed to incorporate these changes.
  • Acción
    Device Technologies is providing their customers with a new “Quick Reference Guide” and requesting that reprocessing G5 and G8 type endoscopes is discontinued until the correct flow unit #7 is provided.

Device

Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes
  • Modelo / Serial
    Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI EndoscopesMultiple FUJINON G5 and G8 Type Flexible GI Endoscope series affectedARTG Number: 112590
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd