Events

Rappel de Intuitive Surgical da Vinci Patient Side Manipulators

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Intuitive Surgical Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15753
  • Date de mise en oeuvre de l'événement
    2013-11-28
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Cause
    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.
  • Action
    Product to be modified

Device

Intuitive Surgical da Vinci Patient Side Manipulators
  • Modèle / numéro de série
    Model: da Vinci S, Si and Si-e Patient Side cart, Affected:
  • Manufacturer
    Intuitive Surgical Inc

Manufacturer

Intuitive Surgical Inc