Events

Rappel de Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si 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-2015-RN-00135-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-19
  • 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-00135-1
  • 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 the harmonic ace ifu contains incorrect instructions in regard to the proper use of the instrument release kit (irk) (or “emergency grip release allen wrench”). the harmonic ace ifu instructs the user to turn the irk counter-clockwise. the correct instruction is to turn the irk clockwise.
  • Action
    Users are asked to discard the current Harmonic Ace IFUs (IFU Part number: 550635-01, 550635-02 550635-03, 550635-04) that they may have. Users are asked to refer to either the Instruments and Accessories User Manual, the Quick Reference Guide that is physically attached to the system, and the metal instruction card that is attached to the IRK provide step-by-step instructions on how to properly perform the emergency grip release.Please also note that the Instruments and Accessories User Manual contain other warnings not listed in the IFU or have information listed in more detail. This action has been closed-out on 15/07/2016.

Device

Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)
  • Modèle / numéro de série
    Intuitive Harmonic ACE Instruments (used with the da Vinci Standard, S, and Si Surgical Systems)5mm Harmonic ACE instrumentsProduct Codes: INS-400274, INS-4002758mm Harmonic ACE instrumentsProduct Codes: INS-420274, INS-420275Harmonic ACE Curved Shears Disposable InsertProduct Code: INS-400272ARTG number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd