Events

Rappel de Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia Pty Ltd.

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
    RC-2013-RN-01248-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01248-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Intuitive surgical has become aware that friction within certain patient side manipulators (ie, instrument arms) can interrupt smooth instrument motion. this interruption is felt by the surgeon as resistance in the movement of the mast. in this situation, the instrument can stall momentarily and then suddenly catch up to the master position if the surgeon pushes through the resistance. this resistance is most noticeable when moving the instrument at very slow speeds and during small movements of the masters. this system behaviours is not autonomous instrument motion. the variable function is immediately apparent to the surgeon, and they would exercise surgical judgment to continue use in only situations where the risk is low. however, they would not necessarily be anticipating an interruption of smooth instrument motion, so may not avoid all vulnerable structures.
  • Action
    Device Technologies is testing affected Patient Side Manipulators (instrument arms) and replacing or repairing instrument arms as required. Device Technologies in providing work around instructions for users to follow as an interim measure.

Device

Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactu...
  • Modèle / numéro de série
    Patient Side Manipulators - da Vinci S, Si, Si-e Surgical System (robotic surgical unit)Manufactured from October 2012 to April 2013ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd