Events

Retiro De Equipo (Recall) de ED-530TK Duodenoscope

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fujifilm 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-2018-RN-00146-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-27
  • 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-2018-RN-00146-1
  • 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
    In response to recent concerns regarding the ability to thoroughly clean duodenoscopes, fujifilm has redesigned some components of the ed-530xt duodenoscope. corrective actions for the ed-530xt include replacement of the forceps elevator mechanism and o-ring seal, replacement of the distal end cap, and new operation manual. the updated design, maintenance schedule and labelling have all been implemented to help reduce any potential risk to health that may be associated with inadequate reprocessing of the device.Fujifilm, through the distributor c.R. kennedy & co, will provide a revised operation manual to be followed. below is the main update to the operation manual:- added the requirement for the ed-530xt to be returned to local fujifilm dealer or authorised service representative for inspection and replacement of the forceps elevator seal once a year to maintain safe use of the device.
  • Acción
    FujiFilm is advising users to review and update the handling and re-processing procedures. Affected products will be serviced to replace the affected parts.

Device

ED-530TK Duodenoscope
  • Modelo / Serial
    ED-530TK DuodenoscopeSerial Numbers: MD102A129, MD102A130, 1D102K227, 1D102K388, 1D102K394, 1D102K436, 1D102K460, D102K508, 1D102K517ARTG Number: 139172(Fujifilm Australia - Duodenoscope, flexible, video - Dudoenoscope, flexible, video)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd