Events

Rappel de Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

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-01110-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-16
  • 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-01110-1
  • 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
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in: 1. a break in the roll gear and/or instrument shaft 2. damage to the push/pull mechanism that controls grip opening and closingif a da vinci si single-site instrument grip cannot be released normally or by opening the masters or the instrument release kit (irk), the surgeon may need to excise tissue in order to extract the instrument.
  • Action
    The customer is to inspect and remove any instrument that shows signs of damage. If the instrument grips remain closed on tissue during surgery and the IRK cannot be used, the surgeon is to follow the instructions in the User Manual addendum to manually release the grip. The sponsor is to arrange the return of the product and credit. This action has been closed-out on 18/04/2017.

Device

Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

Manufacturer

Device Technologies Australia Pty Ltd