Events

Retiro De Equipo (Recall) de da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC Touchpad

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-00312-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-22
  • 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-00312-1
  • 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 found that compact flash cards used in touchpads on specific da vinci si and xi surgical systems to save user preferences, have the potential to become corrupted when the touchpads experience an abrupt power loss and/or are powered on and off within a short period of time. the corruption of the compact flash occurs when power is cycled. if the compact flash has been corrupted, the da vinci system will display a fault during the start-up of the system. in the worst case scenario, the da vinci surgical system will encounter a non-recoverable fault, preventing use of the system. the error typically presents itself during start-up, so will not likely occur during a procedure (unless a mid-procedure power restart is required).
  • Acción
    Device Technologies is advising users that a representative will be replacing the affected compact flash cards with unaffected products. This may require users to re-enter their user preferences. This action has been closed-out on 27/01/2017.

Device

da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC Touchpad
  • Modelo / Serial
    da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC TouchpadPart Number:187505-04 da Vinci Xi PSC TouchpadPart Number: 187716-03 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd