Events

Retiro De Equipo (Recall) de ROSA Brain and ROSA One Surgical Robots

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-2017-RN-00699-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-26
  • 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-2017-RN-00699-1
  • 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
    Medtech has identified a potential software issue for certain rosa brain and rosa one devices than can prevent it reaching a planned trajectory. when the robot arm is automatically sent onto a trajectory, cartesian coordinates are converted to joint configuration through a mathematical model, and for a very limited number of positions, the mathematical model is imperfect and may prevent the robot arm from reaching the desired position.For automatic moves, if the robot is sent to an unreachable trajectory, the device will display an error message and shut down. a delay of surgery can occur.For “isocentric micromoves” mode used during brain surgery, a hazardous situation can occur if an automatic micro movement to trajectory is planned and an instrument is inside the patient anatomy. if not detected by the user, this could lead to ineffective treatment, serious injury, or even death of the patient.To date medtech has not recorded any complaints for this issue.
  • Acción
    Surgicom is currently working on a software correction for this issue, which is expected to be available in July 2017. Surgicom will contact users to arrange for installation of the software update. In the interim, users are to discontinue use of the micromovement function in isocentric mode during brain surgery. In addition, if the issue occurs for other automatic moves, when the error message "A difference in the expected and the actual robot position has been detected. The device will shut down" is displayed users are advised to follow the directions regarding restart and continuation of use of the device that are included in the customer letter.

Device

ROSA Brain and ROSA One Surgical Robots
  • Modelo / Serial
    ROSA Brain and ROSA One Surgical RobotsROSA Brain 3.0.0 Robotic Surgical AssistantSerial Number: BR15002ROSA One 3.1.0 Robotic Surgical AssistantSerial Number: BS16001ARTG Number: 235379 and 278903
  • Manufacturer
    Surgicom Pty Ltd

Manufacturer

Surgicom Pty Ltd
  • Source
    DHTGA