Events

Retiro De Equipo (Recall) de ENDOEYE HD II Rigid Videoscope

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-00197-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-02-09
  • 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-00197-1
  • 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
    Olympus is extending the previous recall for product correction (tga ref.: rc-2015-rn-01141-1) from selected serial numbers to all serial numbers in the market. endoeye distal end can under certain circumstances become hot if the temperature sensor at the device’s tip is damaged (a mechanical breakage of the temperature sensor). although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.As part of the previous action selected serial numbers had the fog-free function disabled due to the backup mechanism (software) designed to detect and identify the failed temperature sensor was not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. this was shortly followed by phase ii correction to replace the hardware (cable) and restore full functionality of the fog-free function.
  • Acción
    Users are advised to discontinue the use of any affected devices in their inventory. Olympus Field Service will schedule a time for to deactivate the fog-free function on the device. The visualisation of the devices will be unaffected and they can be immediately returned to routine use following correction. Customers will be notified once Olympus has concluded the technical investigation and established the permanent solution.

Device

ENDOEYE HD II Rigid Videoscope
  • Modelo / Serial
    ENDOEYE HD II Rigid VideoscopeItem codes : WA50040A and WA50042A All serial numbersARTG Number: 121101
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd