Events

Rappel de da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards

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-2018-RN-00231-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • 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-2018-RN-00231-1
  • 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 circuit boards in specific da vinci x surgical system arms are susceptible to early failures that may result in system faults. the affected arms include arm controller joint circuit boards manufactured with components from a specific manufacturing lot that, due to manufacturing variations, may fail prematurely.As indicated in the user manual, if an arm-specific fault occurs on a system during a procedure and the fault cannot be recovered, the affected arm can be disabled and the procedure may be continued with three arms.If a fault that is not arm-specific occurs, restarting the system may clear the fault. however, the fault may recur. the user may then decide to abort the da vinci procedure or convert to an alternate surgical method.There have been no patient injuries as a result of this issue.
  • Action
    Device Technologies will be replacing the affected Arm Controller Joint Circuit Boards as a permanent correction.

Device

da Vinci X Patient Side Cart Arm Controller Joint Circuit Boards
  • Modèle / numéro de série
    da Vinci X Patient Side Cart Arm Controller Joint Circuit BoardsModel Number: IINS-IS4200Serial Number: SL0015ARTG Number: 97348(Device Technologies Australia - Robot, surgical, operation unit)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd