Events

Retiro De Equipo (Recall) de Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)

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-00583-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-13
  • 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-2013-RN-00583-2
  • 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 has received a small number of customer complaints regarding damaged 5mm cannula which could lead to difficulty inserting or utilising 5mm surgical instruments. using a damaged or bent cannula can result in the loss of smooth instrument motion and/or particles of instrument shaft material being generated, which may drop into the patient.
  • Acción
    Device Technologies is updating the current instructions for use with a modified inspection process for the identification of damaged or bent cannula using an obturator which will be provided to users.

Device

Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)
  • Modelo / Serial
    Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)5mm CannulaProduct code: INS-4200115mm Flared CannulaProduct code: INS-420262ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd