Events

Rappel de Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software

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-01414-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-31
  • 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-01414-1
  • 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
    It has been identified that during an internal test, the left hand control (master) on the surgeon console moved unexpectedly upon the first entry into following mode. the system is in following mode when the surgeon is controlling the instruments at the surgeon console. this behaviour was determined to be associated with a software anomaly in the da vinci xi surgical system p5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances. certain interactions with the patient cart (during patient cart docking, or during multi-port procedures, repositioning the instrument arm) can trigger this behaviour upon entering following mode. the surgeon may receive a recoverable error, experience movement of the master controller and/or movement of the associated cannula/instrument in any direction including potential lateral movement. there is a remote probability of patient harm associated with this issue.
  • Action
    A software update will be released by Intuitive Surgical to address the anomaly which is expected in quarter 1 2017. In the interim, to prevent this event from occurring, users are advised to follow the instructions below during every da Vinci Xi procedure: 1.During Single-Site surgery, after installing each instrument on the sterile adapter, ensure instrument clutch is not activated and press the port clutch* button for that arm. This is only necessary at the beginning of the procedure, directly after the docking. 2.During Multi-Port surgery: - Immediately after docking to a cannula, press the corresponding port clutch button for that arm, and - If adjusting patient clearance and mid-procedure, ensure instrument clutch is not activated and press the corresponding port clutch button for that arm after the adjustment. This action has been closed-out on 11/05/2017.

Device

Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 soft...
  • Modèle / numéro de série
    Intuitive Surgical Endoscope Instrument Control System - da Vinci Xi Surgical System with P5 software Model Number: INS-IS4000ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd