Events

Retiro De Equipo (Recall) de 10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope

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-2018-RN-00841-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-07-02
  • 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-00841-1
  • 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
    The manufacturer olympus winter & ibe has updated section 7.9.1 gas sterilisation in the instructions for use for the wair100a and wair130a to include the following warning:“warningrisk of injury to the patient and usertoxic gasses can enter internal volumes of the product during gas sterilisation. the gasses can remain in the product and can leak out during use.· to remove toxic gasses, aerate the product sufficiently after sterilisation.”.
  • Acción
    Olympus is requesting users: 1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control; 2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU; 3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and 5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.

Device

10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared Telescope
  • Modelo / Serial
    10mm 0Deg Infrared Telescope and 10mm 30Deg Infrared Telescope10mm 0Deg Infrared TelescopeModel Number: WAIR100A10mm 30Deg Infrared TelescopeModel Number: WAIR130AAll Lot/Serial NumbersARTG Number: 146202(Olympus Australia Pty Ltd - Endoscope element, telescope)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd