Events

Retiro De Equipo (Recall) de da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards

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-2018-RN-00231-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-13
  • 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-2018-RN-00231-1
  • 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 become aware that circuit boards in specific da vinci x surgical system arms are susceptible to early failures that may result in system faults. the affected arms include arm controller joint circuit boards manufactured with components from a specific manufacturing lot that, due to manufacturing variations, may fail prematurely.As indicated in the user manual, if an arm-specific fault occurs on a system during a procedure and the fault cannot be recovered, the affected arm can be disabled and the procedure may be continued with three arms.If a fault that is not arm-specific occurs, restarting the system may clear the fault. however, the fault may recur. the user may then decide to abort the da vinci procedure or convert to an alternate surgical method.There have been no patient injuries as a result of this issue.
  • Acción
    Device Technologies will be replacing the affected Arm Controller Joint Circuit Boards as a permanent correction.

Device

da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards
  • Modelo / Serial
    da Vinci X Patient Side Cart Arm Controller Joint Circuit BoardsModel Number: IINS-IS4200Serial Number: SL0015ARTG Number: 97348(Device Technologies Australia - Robot, surgical, operation unit)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd