Events

Rappel de Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems

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-2013-RN-01294-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-12-09
  • 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-2013-RN-01294-1
  • 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 has become aware of the potential for detachment of the jaw insert for large needle drivers and mega needle drivers. only large needle driver and mega needle driver instruments manufactured between july 2007 and october 2011 are affected. if a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
  • Action
    Device Technologies is advising users to quarantine affected devices from use. Affected devices can be returned to Device Technologies.

Device

Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems
  • Modèle / numéro de série
    Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical SystemsLarge Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420006Mega Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420194Large Needle Driver, da Vinci StandardProduct Number: INS-400006Mega Needle Driver, da Vinci StandardProduct Number: INS-400194.Multiple Lot Numbers affectedManufactured between July 2007 and October 2011ARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd