Events

Rappel de Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM 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-00892-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-02
  • 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-00892-1
  • 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
    Patient side cart battery boxes returned to intuitive surgical from the field have revealed, in some rare charging conditions, the battery has been found to heat sufficiently to cause the battery case to bulge. a battery case that has bulged has the potential to release some of its internal gases to the surrounding air. the da vinci stm and da vinci sitm surgical systems are designed to detect overheating batteries and issue a system warning, error code 808 is displayed on the surgeon console and patient side cart monitors. when this event is detected, the system disables the charging of the battery until it cools down.
  • Action
    Users are advised that they may continue to use their da Vinci S, Si and Si-e Patient Side Carts. However, if users receive an Error Code 808, or experience a sulfur odour while using da Vinci STM or da Vinci SiTM Surgical System, they are advised to contact their Device Technologies representative, following standard troubleshooting process. For product already in use, Device Technologies is utilising standard repair and preventative maintenance programs to monitor battery performance and perform battery replacement as needed. This action has been closed-out on 06/06/2016.

Device

Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical Systems
  • Modèle / numéro de série
    Intuitive Surgical Battery Box of the da Vinci STM and da Vinci SiTM Surgical SystemsProduct number for the battery box: 371268-02 Manufactured between 22 November 2005 and 09 July 2012ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd