Events

Retiro De Equipo (Recall) de da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systems

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-2014-RN-01310-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-07
  • 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-2014-RN-01310-1
  • 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
    Intuitive surgical has received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in labelling for the da vinci s, si or si-e surgical system, instruments and accessories.Intuitive surgical is initiating a correction related to labelling updates to distributed user manuals, instructions for use (ifu), quick reference guides (qrg)and the natural rubber latex qrg as well as an instrument release kit (irk) for use with da vinci surgical systems, instruments and accessories. the labelling updates have been implemented to incorporate user feedback not previously addressed.
  • Acción
    Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016.

Device

da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vi...
  • Modelo / Serial
    da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systemsAll Serial Numbers are affected Model Numbers: IS1200, IS2000, IS3000 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd