Events

Rappel de CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par ConMed Linvatec 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-2016-RN-01129-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-08-26
  • 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-2016-RN-01129-1
  • 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 received complaints of damage to the electrode shaft insulation, which could increase the risk of a patient burn.To date, conmed has not received any reports where this has led to illness or injury.
  • Action
    ConMed Linvatec is advising users to immediately discontinue use of the affected product and to return it to ConMed Linvatec for credit or replacement. This action has been closed-out on 10/05/2017.

Device

CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode ...
  • Modèle / numéro de série
    CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)Reference/Catalogue Number: CS-023Affected Lots: 267221 to 695063ARTG Number: 94017
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd