Events

Rappel de ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

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-2014-RN-00522-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-05-09
  • 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-2014-RN-00522-1
  • 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 advised they have received complaints that the electrode gel may make contact with an internal staple causing no output, sparking and heat build-up between the staple and the electrode foil contact surface. whilst there have been no complaints and no reports of injury or death received by the product sponsor in australia, one patient in japan was reported to have received a skin tear.
  • Action
    ConMed is requesting their customer to immediately discontinue the use of the device and arrange for its return. This action has been closed-out on 29/01/2016.

Device

ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

Manufacturer

ConMed Linvatec Australia Pty Ltd