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-2018-RN-00500-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-05-17
  • 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-2018-RN-00500-1
  • 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
    In march 2017, device technologies australia (dta) in conjunction with intuitive surgical sent correspondence (tga ref rc-2017-rn-00440-1) highlighting the proper use of the da vinci xi endowrist stapler release kit (srk) tool and providing additional information regarding the use of the instrument release kit (irk) tool as a backup if a srk tool was not available.Further to this, intuitive surgical has now developed an improved da vinci xi endowrist stapler release kit (srk) tool, which reduces the likelihood of breakage. please note that the instructions for use (ifu) remain the same.
  • Action
    Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process. Users are reminded to refer to the IFU for appropriate use of the device.

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 KitObsolete Product Code: INS-381215New Product Code: INS-381215-03Part Number: 381215-02ARTG Number: 228401(Device Technologies Australia - Wrench, surgical)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd