Events

Retiro De Equipo (Recall) de Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)

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-2013-RN-01044-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-10-14
  • 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-2013-RN-01044-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, intuitive surgical inc, is informing customers that the incorrect version of the user manual associated with the single-site instruments, specifically the bipolar maryland and curved needle driver instruments, was not distributed to customers prior to shipment and use of the instruments.
  • Acción
    Device Technologies is notifying their customers of the issue. A Device Technologies representative will contact each customer to organise the delivery of the correct User Manual. Customers are requested to discard the previous version once the new User Manual has been received. This action has been closed-out on 10/02/2016.

Device

Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device wi...
  • Modelo / Serial
    Single-Site Bipolar Maryland and Single-Site Curved Needle Driver (Reusable endotherapy device with an endoscope)Single-Site Bipolar MarylandProduct Code: INS-428080Single-Site Curved Needle DriveProduct Code: INS-428088ARTG Number: 132453, 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd