Events

Retiro De Equipo (Recall) de Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013

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-01248-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-27
  • 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-01248-1
  • 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 become aware that friction within certain patient side manipulators (ie, instrument arms) can interrupt smooth instrument motion. this interruption is felt by the surgeon as resistance in the movement of the mast. in this situation, the instrument can stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance. this resistance is most noticeable when moving the instrument at very slow speeds and during small movements of the masters. this system behaviours is not autonomous instrument motion. the variable function is immediately apparent to the surgeon, and they would exercise surgical judgment to continue use in only situations where the risk is low. however, they would not necessarily be anticipating an interruption of smooth instrument motion, so may not avoid all vulnerable structures.
  • Acción
    Device Technologies is testing affected Patient Side Manipulators (instrument arms) and replacing or repairing instrument arms as required. Device Technologies in providing work around instructions for users to follow as an interim measure.

Device

Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactu...
  • Modelo / Serial
    Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd