Events

Retiro De Equipo (Recall) de Rosa One 3.1(Surgical robot for spine and brain surgeries)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Surgicom 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-01658-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-09
  • 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-01658-1
  • 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
    Two software issues have been identified with the rosa one 3.1.1. specific to spinal surgery application - a product complaint was received by the manufacturer that indicated a risk for robot collision. when driving the robot arm in a surgical procedure, the robot arm comes too close to the robot stand, which leads to the possiblity of colliding with the stand. this issue was further observed during multiple attempts to enable the function "clear the arm (cooperative mode)". the rosanna spine software (version 3.1.0.1225) was identified as non-conforming to the release design.2. specific to brain surgery application - part of the rosa one 3.1 mario software (robot arm software) related to safety in the "cooperative mode" is currently deactivated. the risk of unwanted robot motion with an instrument into the anatomy is mitigated by this software measure.To date, their have been no injuries reported due to these issues.
  • Acción
    Software corrections for the Rosa One 3.1 will be performed on site. The Rosanna Spine software correction has occured. Until the Mario software for the brain application is modifed, usage of the device is to be limited to the spine application only. This action has been closed-out on 09/06/2017.

Device

Rosa One 3.1(Surgical robot for spine and brain surgeries)
  • Modelo / Serial
    Rosa One 3.1(Surgical robot for spine and brain surgeries)Item Number: ROSA00208Serial Number: BS16001ARTG Number: 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA