Events

Rappel de da Vinci Xi EndoWrist Stapler Release Kit (SRK)

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-2017-RN-00440-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-04-04
  • 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-2017-RN-00440-1
  • 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 received complaints where the srk tool has broken during use. it was determined that misinterpretation of instructions provided on the is4000 srk instruction card may result in damage of the tool. there have been three clinical cases where the endowrist stapler jaws would not open while clamped on tissue, the srk tool broke, and the stapler was excised using an alternative stapling device or other surgical intervention. the risk to health due to the srk tool breakage can range from the minor delay in surgery in order to locate and use a backup srk or instrument release kit (irk) tool, to extracting the clamped tissue from the stapler jaws, to the worst case scenario of the clamped tissue needing to be excised using an alternative stapling device or other surgical intervention. device technologies wish to reiterate the proper use of the srk tool, and to provide additional instructions in the scenario of srk tool damage.
  • Action
    Device Technologies is advising users in the scenario where the SRK needs to be used, to follow all instructions as provided in the da Vinci Xi EndoWrist Stapler Instruments and Accessories User Manual Addendum and reiterated in the customer letter. If the SRK tool breaks, proceed with the instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and contact your Device Technologies representative to arrange for SRK return through the product complaints process.

Device

da Vinci Xi EndoWrist Stapler Release Kit (SRK)
  • Modèle / numéro de série
    da Vinci Xi EndoWrist Stapler Release Kit (SRK)Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release KitProduct Code: INS-381215Part Number: 381215-02ARTG Number: 228401
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd