Events

Retiro De Equipo (Recall) de da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000

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-01265-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-24
  • 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-01265-1
  • 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 manufacturer intuitive surgical has identified specific configurations in which monopolar energy has the potential to be transmitted from the da vinci xi endoscope shaft to tissue it is contacting. although there have been no reported complaints related to this issue, these configurations have the potential to result in unintended thermal injury.
  • Acción
    The sponsor is advising users to follow the instructions given in the customer letter to mitigate the risk of thermal injury, specifically: • Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced via the 12 mm da Vinci cannula. This is the case whether or not the da Vinci 12 mm to 8 mm cannula reducer is used. • Never insert a da Vinci Xi cannula into another cannula placed in the patient’s body wall (i.e. double cannulation). • Use caution when using monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured. This action has been closed-out on 28/02/2018.

Device

da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000
  • Modelo / Serial
    da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000Part numbers: 470026-34, 470026-40, 470026-41 DT ordering code: INS-470026 30 deg, 8mm Endoscope, IS4000 Part numbers: 470027-34, 470027-40, 470027-41 DT ordering code: INS-470027 Affected User Manual:Part number: 551706Language: English ARTG: 99242
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd