Events

Retiro De Equipo (Recall) de Stellaris PC with Laser System (Cataract extraction/vitrectomy 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 Bausch & Lomb 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-01205-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-13
  • 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-01205-1
  • 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 stellaris pc has a software fault, when in surgery, if the surgeon requests a laser sub-mode change (i.E. from endo to endo continuous) and the system is in “standby”, the system will automatically transition from “standby” to “ready” to fire. if the system moves to ready from standby, and this has not been specifically commanded by the surgeon or the nurse, it raises the possibility that this change may not have been noticed and that the foot pedal could be depressed and the laser may fire unexpectedly.
  • Acción
    Bausch and Lomb has developed a software update to address the situation, which will be installed in the affected system. In the meantime, users may continue to use the Stellaris PC laser system. However, they are advised not to request the Laser sub-mode change from Endo to Endo Continuous during surgery until the software update has been implemented. This action has been closed-out on 06/06/2016.

Device

Stellaris PC with Laser System (Cataract extraction/vitrectomy system)
  • Modelo / Serial
    Stellaris PC with Laser System (Cataract extraction/vitrectomy system)Product Code: BL14304Serial Number : SPC02059ARTG Number: 127264
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd