Events

Rappel de Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)

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-00583-2
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-13
  • 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-00583-2
  • 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 has received a small number of customer complaints regarding damaged 5mm cannula which could lead to difficulty inserting or utilising 5mm surgical instruments. using a damaged or bent cannula can result in the loss of smooth instrument motion and/or particles of instrument shaft material being generated, which may drop into the patient.
  • Action
    Device Technologies is updating the current instructions for use with a modified inspection process for the identification of damaged or bent cannula using an obturator which will be provided to users.

Device

Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)
  • Modèle / numéro de série
    Intuitive Surgical 5mm Cannula and 5mm Flared Cannula (Reusable endotherapy cannula)5mm CannulaProduct code: INS-4200115mm Flared CannulaProduct code: INS-420262ARTG Number: 97289
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd