Events

Rappel de Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site 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-2014-RN-00520-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-12
  • 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-00520-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, intuitive surgical inc., is issuing this recall for product correction for 5mm curved cannula for single-site instruments, to update the user manual. as indicated in the user manual addendum, cannula damage can include cracks in the tube or bowl/tube interface and tube wall anomalies etc and may result from incorrect placement of the cannulae. if cannula damage occurs during a procedure, then there is a possibility that the cannula or associated instrument may come in inadvertent contact with tissue and generate excessive forces on the patient body wall. this contact may cause tissue injury and require additional surgical and/or medical intervention.
  • Action
    The “Single-Site Cannula Inspection and Use – Single-Site User Manual Addendum” will be hand delivered to the Nurse Unit Manager by your Product Specialist.

Device

Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical Sy...
  • Modèle / numéro de série
    Intuitive Surgical Inc. – 5mm Curved Cannula for Single-Site Instruments for da Vinci Surgical SystemsAffected Products:INS-428061 5 X 300MM CURVED CANNULA ARM 1INS-428062 5 X 300MM CURVED CANNULA ARM 2INS-428071 5 X 250MM CURVED CANNULA ARM 1INS-428072 5 X 250MM CURVED CANNULA ARM 2ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd