Events

Retiro De Equipo (Recall) de Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2012-RN-00819-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-13
  • 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-2012-RN-00819-3
  • 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
    Pentax has been notified of a potential risk related to the use of the eg-3870utk ultrasound video gastroscope in combination with aspiration needles if the instructions for use is not followed carefully by the user. specifically, if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle could disengage from the elevator.
  • Acción
    Customers are being provided with revised instructions for use (IFU) which should be read and followed by the users of the equipment. The owners manual is to be updated with the addendum that has been provided by the Sponsor.

Device

Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

Manufacturer

Device Technologies Australia Pty Ltd