Events

Retiro De Equipo (Recall) de Intuitive Surgical da Vinci Patient Side Manipulators

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Intuitive Surgical Inc.

¿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
    15753
  • Fecha de inicio del evento
    2013-11-28
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Manufacturer has become aware that friction within certain instrument arms can interrupt smooth instrument motion. this interruption is felt by by the surgeon as resistance in the movement of the master. in this situation the instrument can stall momentarily and then suddenly catch-up to the master psition id the surgeon pushes through the resistance. this resistance is most noticeable when moving the instruments at very slow speeds and during small movements of the masters. this system behaviour is not autonomous instrument motion.
  • Acción
    Product to be modified

Device

Intuitive Surgical da Vinci Patient Side Manipulators
  • Modelo / Serial
    Model: da Vinci S, Si and Si-e Patient Side cart, Affected:
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc