Events

Rappel de da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systems

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-2014-RN-01310-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-07
  • 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-2014-RN-01310-1
  • 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 received 66 unique adverse event reports associated with product use scenarios that were not previously addressed in labelling for the da vinci s, si or si-e surgical system, instruments and accessories.Intuitive surgical is initiating a correction related to labelling updates to distributed user manuals, instructions for use (ifu), quick reference guides (qrg)and the natural rubber latex qrg as well as an instrument release kit (irk) for use with da vinci surgical systems, instruments and accessories. the labelling updates have been implemented to incorporate user feedback not previously addressed.
  • Action
    Device Technologies is advising their customers of the changes to labelling and requesting that superseded versions are discarded and replaced with the updated product information. End users are also requested to discard the Emergency Grip Release Wrench and replace with the Instrument Release Kit which includes the release wrench and an attached instruction card. This action has been closed-out on 14/07/2016.

Device

da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vi...
  • Modèle / numéro de série
    da Vinci Standard Surgical System, da Vinci S Surgical System, da Vinci Si Surgical System, da Vinci Si-e Surgical System including all instruments and accessories used with the da Vinci surgical systemsAll Serial Numbers are affected Model Numbers: IS1200, IS2000, IS3000 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd