Events

Retiro De Equipo (Recall) de da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

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-01067-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-15
  • 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-01067-1
  • 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 patient cart is a robotic platform used for da vinci surgery. during normal use the cart can be exposed to small amounts of fluids from the environment (during cleaning for example) without impairing function. improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers. during surgical procedures there is also a small risk that fluid can be transferred inside the patient cart, for example, biological or i.V. fluids. the system user manual at the time instructed the user to contact intuitive surgical in the cases where components came into contact with liquids. however, there was no specific warning about the consequences of exposure to liquids. this recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Acción
    Device Technologies has installed a fluid ingress protection kit on all IS2000 and IS3000 systems.

Device

da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

Manufacturer

Device Technologies Australia Pty Ltd