Events

Rappel de EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-00328-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-17
  • 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-2013-RN-00328-1
  • 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 has identified an increase in adverse events with enseal g2 superjaw for suspected thermal injuries related to the use of the device.
  • Action
    Johnson & Johnson Medical (JJM) is updating the instructions for use to prevent the issues from occurring in the field. JJM has advised the TGA that they are further reviewing the post-market surveillance data and will advise the TGA regarding the outcomes of this review.

Device

EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during lapa...
  • Modèle / numéro de série
    EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)Product Code: NSEALX22LARTG Number: 165469
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd