Events

Rappel de da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer

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-00222-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • 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-00222-1
  • 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 identified the potential for a certain, small portion of vessel sealers to exhibit interference in the proximal end (near the joint) of the instrument grips. this interference is due to manufacturing variability in some jaws. the interference can lead to contact between the instrument electrodes at the back of the jaws and subsequent shorting of the electrosurgical energy. the shorting behaviour can lead to extended activation times and insufficient energy delivery to thin, vascular tissue bundles, leading to bleeding if transected. this issue has been identified on a small population of vessel sealers only when used on thin, vascular tissue. there has been no impact identified to sealing performance on larger vessels or tissue bundles.
  • Action
    Device Technologies Australia (DTA) is informing the customers of the potential for insufficient energy delivery on a small population of Vessel Sealers only when used on thin, vascular tissue and providing instructions on alternative methods of sealing and transection. In caseWhere the customer does not wish to use affected Vessel Sealer instruments, DTA is offering a full credit refund for affected stock in its original packaging. This action has been closed-out on 08/08/2016.

Device

da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoW...
  • Modèle / numéro de série
    da Vinci Si EndoWrist One Vessel Sealer and da Vinci Xi EndoWrist Vessel Sealer da Vinci Si EndoWrist One Vessel Sealer Product Code: 410322-05; Order code INS-410322Multiple Lot Numbersda Vinci Xi EndoWrist Vessel Sealer Product Code: 480322-04; Order Code INS-180322Multiple Lot NumbersARTG Number: 132453
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd