Events

Rappel de da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC Touchpad

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-2016-RN-00312-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-22
  • 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-2016-RN-00312-1
  • 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 found that compact flash cards used in touchpads on specific da vinci si and xi surgical systems to save user preferences, have the potential to become corrupted when the touchpads experience an abrupt power loss and/or are powered on and off within a short period of time. the corruption of the compact flash occurs when power is cycled. if the compact flash has been corrupted, the da vinci system will display a fault during the start-up of the system. in the worst case scenario, the da vinci surgical system will encounter a non-recoverable fault, preventing use of the system. the error typically presents itself during start-up, so will not likely occur during a procedure (unless a mid-procedure power restart is required).
  • Action
    Device Technologies is advising users that a representative will be replacing the affected compact flash cards with unaffected products. This may require users to re-enter their user preferences. This action has been closed-out on 27/01/2017.

Device

da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC Touchpad
  • Modèle / numéro de série
    da Vinci Si and Xi Surgical System - Touchpad Compact Flashcardsda Vinci Si/Xi SSC TouchpadPart Number:187505-04 da Vinci Xi PSC TouchpadPart Number: 187716-03 ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd