Events

Retiro De Equipo (Recall) de HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03

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-00863-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-14
  • 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-00863-1
  • 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 has updated the instructions for use (ifu) for the hf resection electrodes. the ifu has been updated to include new contraindications, warnings and safety information.
  • Acción
    Olympus is asking customers to: 1. Inspect inventory and replace any existing IFUs supplied with the device as per the list on Appendix A with the latest version provided in the customer letter; 2. Ensure all personnel are trained and/or familiarised themselves with the added contraindications, warnings and safety information as stated. Do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 3. Complete the supplied reply form as per the instructions given; 4. If you have distributed or transferred any of the affected items from your facility to another, please forward this recall notice and also please notify Olympus so that we can follow up with that facility directly; 5. If you require additional hard/electronic copies of the IFU, please email RA@Olympus.com.au; and 6. If you have any queries or concerns in relation to this matter please do not hesitate to contact Olympus Customer Operations on 1300 657 699 or email RA@Olympus.com.au.

Device

HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope I...
  • Modelo / Serial
    HF-Resection ElectrodesMonopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03Multiple Item NumbersARTG Numbers: 146187 and 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd