Events

Rappel de da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

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-01067-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-15
  • 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-01067-1
  • 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 patient cart is a robotic platform used for da vinci surgery. during normal use the cart can be exposed to small amounts of fluids from the environment (during cleaning for example) without impairing function. improper cleaning techniques involving application of excessive amounts of fluid in a splashing or spraying manner can result in penetration of fluids inside the covers. during surgical procedures there is also a small risk that fluid can be transferred inside the patient cart, for example, biological or i.V. fluids. the system user manual at the time instructed the user to contact intuitive surgical in the cases where components came into contact with liquids. however, there was no specific warning about the consequences of exposure to liquids. this recall action was carried out prior to approval of the recall strategy by the therapeutic goods administration.
  • Action
    Device Technologies has installed a fluid ingress protection kit on all IS2000 and IS3000 systems.

Device

da Vinci S Surgical System, IS2000; da Vinci Si Surgical System IS3000

Manufacturer

Device Technologies Australia Pty Ltd