Events

Retiro De Equipo (Recall) de Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

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-2014-RN-00759-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-07
  • 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-2014-RN-00759-1
  • 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 inc. have become aware of the larger clip applier instrument jamming or feeling friction during insertion into the 8mm cannula or into certain cannula reducer accessories. no adverse events have been reported due to this issue. if an instrument gets jammed in the cannula or reducer accessory during insertion this may prevent or delay the use of the instrument. as the type of clip applied by the clip applier is used to occlude controlled vessels rather than during episodes of active bleeding, a delay in clip application will have no immediate or long term health consequences for the patient.
  • Acción
    A software update has been developed to correct the issue. The product may continue to be used while software upgrades are being made in the field. The software upgrade will reduce the degree to which the jaws on the Large Clip Applier Instrument open during insertion and will eliminate the occurrence of jamming.

Device

Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

Manufacturer

Device Technologies Australia Pty Ltd