Events

Rappel de Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

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-00759-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-07-07
  • 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-00759-1
  • 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 inc. have become aware of the larger clip applier instrument jamming or feeling friction during insertion into the 8mm cannula or into certain cannula reducer accessories. no adverse events have been reported due to this issue. if an instrument gets jammed in the cannula or reducer accessory during insertion this may prevent or delay the use of the instrument. as the type of clip applied by the clip applier is used to occlude controlled vessels rather than during episodes of active bleeding, a delay in clip application will have no immediate or long term health consequences for the patient.
  • Action
    A software update has been developed to correct the issue. The product may continue to be used while software upgrades are being made in the field. The software upgrade will reduce the degree to which the jaws on the Large Clip Applier Instrument open during insertion and will eliminate the occurrence of jamming.

Device

Large Clip Applier for use with the da Vinci STM and da Vinci SiTM

Manufacturer

Device Technologies Australia Pty Ltd