Events

Retiro De Equipo (Recall) de Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)

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-00390-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-10
  • 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-00390-1
  • 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 sterile adapter acts as an interface between the sterile surgical instruments and non-sterile system. intuitive surgical is undertaking market action to provide users of the da vinci s, si and si-e systems with additional information regarding sterile adapter engagement and instrument installation. although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments.
  • Acción
    Device Technologies is providing their customers with further training to ensure the correct engagement of the sterile adaptor. Additional quick reference instructions will also be provided.

Device

Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)
  • Modelo / Serial
    Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)Model numbers: da Vinci S - IS2000da Vinci Si - IS3000da Vinci Si-e - IS3000Serial numbers: IS2000 IFU 550516-05; IS3000 IFU 550650-05
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd