Events

Rappel de Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use active endotherapy device used in endoscopic procedures for cutting and or coagulating tissue)

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-2014-RN-01174-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-11-04
  • 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-2014-RN-01174-1
  • 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
    - during a surgical procedure, if the blade does not return to its original position within a specified timeframe, the system determines the instrument has an “exposed blade”. the da vinci si system is designed to display a recoverable fault when an “exposed blade” error occurs. a recoverable fault means that you may continue using the system after addressing the error. activating and firing the knife blade while the jaws are more than 4 mm open increases the likelihood of an exposed blade error. currently, the vessel sealer applies bipolar energy between the electrode surfaces on the interior surface of the instrument jaws in order to coagulate vessels up to 7 mm in size. users are then instructed to keep the master grips fully closed during the sealing cycle. opening the grip on the masters reduces the pressure applied to the vessel during sealing, which may result in insufficient sealing performance.
  • Action
    Device Technologies Australia is informing their customers of the changes to the user manual to reduce the potential for exposed blade errors and providing a software upgrade to reduce the potential for insufficient sealing. Device Technologies Australia is informing the customers to continue using the Endo Wrist One Vessel Sealer. A Device Technologies Australia product specialist / technician will contact the customer and provide the updated User Manual and schedule the software upgrade which will be available in December 2014. This action has been closed-out on 18/07/2016.

Device

Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use...
  • Modèle / numéro de série
    Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use active endotherapy device used in endoscopic procedures for cutting and or coagulating tissue)Model Number: 410322 ARTG Number 132453
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd