Events

Rappel de da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000

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-01265-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-24
  • 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-01265-1
  • 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
    The manufacturer intuitive surgical has identified specific configurations in which monopolar energy has the potential to be transmitted from the da vinci xi endoscope shaft to tissue it is contacting. although there have been no reported complaints related to this issue, these configurations have the potential to result in unintended thermal injury.
  • Action
    The sponsor is advising users to follow the instructions given in the customer letter to mitigate the risk of thermal injury, specifically: • Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced via the 12 mm da Vinci cannula. This is the case whether or not the da Vinci 12 mm to 8 mm cannula reducer is used. • Never insert a da Vinci Xi cannula into another cannula placed in the patient’s body wall (i.e. double cannulation). • Use caution when using monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured. This action has been closed-out on 28/02/2018.

Device

da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000
  • Modèle / numéro de série
    da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000Part numbers: 470026-34, 470026-40, 470026-41 DT ordering code: INS-470026 30 deg, 8mm Endoscope, IS4000 Part numbers: 470027-34, 470027-40, 470027-41 DT ordering code: INS-470027 Affected User Manual:Part number: 551706Language: English ARTG: 99242
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd