Events

Retiro De Equipo (Recall) de Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart Arms

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-2015-RN-00291-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-17
  • 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-2015-RN-00291-1
  • 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 system reports a “23008” system software fault that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. the system may fault during start up tests or during use. the system fault is an arm-specific recoverable fault, which leaves the system in a safe state. a fault message will be displayed and the affected arm led colour will change to yellow. the source of the fault is the premature failure of a position sensor located within the faulting joint. there have been no reported injuries as a result of this issue. in a scenario in which the decision is made to convert a procedure to an alternate surgical method due to the error, the patient may be at higher risk of surgical complications because of the historically higher rate of complications in open surgery.
  • Acción
    A Device Technologies representative will contact affected customers to schedule a remote assessment to determine the health of the systems and further schedule an appointment to replace the affected arm. In the interim, users are advised that if the error persists (i.e. the fault cannot be recovered), the affected arm should be disabled and the user should decide to continue the procedure with 3 arms, abort the procedure, or convert to an alternate surgical technique. This action has been closed-out on 9/08/2016.

Device

Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart Arms
  • Modelo / Serial
    Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart ArmsInner ArmModel Numbers: 380662-20, 380662-21Outer ArmModel Numbers: 380663-20, 380663-21 Universal Surgical ManipulatorModel Numbers: 380647-20, 380647-22ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd