Events

Retiro De Equipo (Recall) de Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software

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-2016-RN-01414-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-31
  • 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-2016-RN-01414-1
  • 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
    It has been identified that during an internal test, the left hand control (master) on the surgeon console moved unexpectedly upon the first entry into following mode. the system is in following mode when the surgeon is controlling the instruments at the surgeon console. this behaviour was determined to be associated with a software anomaly in the da vinci xi surgical system p5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances. certain interactions with the patient cart (during patient cart docking, or during multi-port procedures, repositioning the instrument arm) can trigger this behaviour upon entering following mode. the surgeon may receive a recoverable error, experience movement of the master controller and/or movement of the associated cannula/instrument in any direction including potential lateral movement. there is a remote probability of patient harm associated with this issue.
  • Acción
    A software update will be released by Intuitive Surgical to address the anomaly which is expected in quarter 1 2017. In the interim, to prevent this event from occurring, users are advised to follow the instructions below during every da Vinci Xi procedure: 1.During Single-Site surgery, after installing each instrument on the sterile adapter, ensure instrument clutch is not activated and press the port clutch* button for that arm. This is only necessary at the beginning of the procedure, directly after the docking. 2.During Multi-Port surgery: - Immediately after docking to a cannula, press the corresponding port clutch button for that arm, and - If adjusting patient clearance and mid-procedure, ensure instrument clutch is not activated and press the corresponding port clutch button for that arm after the adjustment. This action has been closed-out on 11/05/2017.

Device

Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 soft...
  • Modelo / Serial
    Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software Model Number: INS-IS4000ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd