Events

Rappel de da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mm

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-00701-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-06-23
  • 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-00701-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, is issuing this warning notice in relation to the use of da vinci xi 5mm-8mm universal cannula seal and da vinci xi 12mm & stapler universal cannula seal in all surgical procedures.During internal inspections, intuitive surgical has identified particulate in the insufflation stopcocks on the da vinci xi 5mm-8mm universal cannula seal. the particulate generated from the seal material has the potential to be introduced into the cannula lumen when insufflation is connected. there have been no injuries reported related to this issue.
  • Action
    Users are advised to not use the da Vinci Xi 5mm-8mm Universal Cannula Seal or the da Vinci Xi 12mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during all types of surgical procedures until this issue is resolved. It is recommended to use an alternative device such as an angio-catheter, Veress needle or laparoscopic trocar for initial access and to maintain insufflation throughout all procedures as an alternative to insufflation through the da Vinci Xi 5mm-8mm Universal Cannula Seal (INS-470361) or the da Vinci Xi 12mm & Stapler Universal Cannula Seal (INS-470380). This action has been closed-out on 20/02/2017.

Device

da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealU...
  • Modèle / numéro de série
    da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mmPart Number: INS-740361 Stapler Universal Cannula Seal, 12mm & StaplerPart Number: INS-470380ARTG Number: 181744
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd