Events

Rappel de Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart Arms

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-2015-RN-00291-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-17
  • 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-2015-RN-00291-1
  • 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 system reports a “23008” system software fault that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. the system may fault during start up tests or during use. the system fault is an arm-specific recoverable fault, which leaves the system in a safe state. a fault message will be displayed and the affected arm led colour will change to yellow. the source of the fault is the premature failure of a position sensor located within the faulting joint. there have been no reported injuries as a result of this issue. in a scenario in which the decision is made to convert a procedure to an alternate surgical method due to the error, the patient may be at higher risk of surgical complications because of the historically higher rate of complications in open surgery.
  • Action
    A Device Technologies representative will contact affected customers to schedule a remote assessment to determine the health of the systems and further schedule an appointment to replace the affected arm. In the interim, users are advised that if the error persists (i.e. the fault cannot be recovered), the affected arm should be disabled and the user should decide to continue the procedure with 3 arms, abort the procedure, or convert to an alternate surgical technique. This action has been closed-out on 9/08/2016.

Device

Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart Arms
  • Modèle / numéro de série
    Intuitive Surgical Inc. da Vinci Xi Surgical System Patient Cart ArmsInner ArmModel Numbers: 380662-20, 380662-21Outer ArmModel Numbers: 380663-20, 380663-21 Universal Surgical ManipulatorModel Numbers: 380647-20, 380647-22ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd