Events

Retiro De Equipo (Recall) de Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus 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-2017-RN-01519-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-19
  • 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-2017-RN-01519-1
  • 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
    Omsc has received a small number of adverse event reports globally for the urf-v2 associated with damage to the bending section. to date, no adverse events have been reported to olympus in australia for the urf-v2 and no adverse events reported globally for the urf-p6. further to olympus’ safety alert issued in december 2016 (rc-2016-rn-01653-1), the manufacturer has modified the design of the bending section of the urf-v2 and urf-p6 to address any deficiencies that may have attributed to the adverse events reported globally.
  • Acción
    Olympus is advising hospitals to identify affected devices from their inventory. When replacement URF-V2 and URV-P6 devices are available, an Olympus Customer Operations Specialist will contact users to exchange devices at affected facilities. In the interim, users may refer to the IFU and Safety Alert issued by Olympus for the correct inspection and use of the device.

Device

Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope
  • Modelo / Serial
    Flexible Uretero-Reno Videoscope & Flexible Uretero-Reno Fiberscope Model Numbers: URF-V2 and URF-P6ARTG Numbers: 211118 and 131068
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd