Events

Rappel de Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)

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-00390-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-10
  • 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-00390-1
  • 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
    The sterile adapter acts as an interface between the sterile surgical instruments and non-sterile system. intuitive surgical is undertaking market action to provide users of the da vinci s, si and si-e systems with additional information regarding sterile adapter engagement and instrument installation. although rare, sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments.
  • Action
    Device Technologies is providing their customers with further training to ensure the correct engagement of the sterile adaptor. Additional quick reference instructions will also be provided.

Device

Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)
  • Modèle / numéro de série
    Sterile Adapter for use with the da Vinci S, da Vinci Si, da Vinci Si-e (robotic surgical system)Model numbers: da Vinci S - IS2000da Vinci Si - IS3000da Vinci Si-e - IS3000Serial numbers: IS2000 IFU 550516-05; IS3000 IFU 550650-05
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd