Events

Rappel de ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CONMED CANADA.

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
    22904
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-02-25
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Conmed canada is sending this reminder to provide important information concerning the proper use of altrus thermal tissue fusion handpieces. the reason for this notification is to reinforce best practices when using energy devices. energy based vessel sealing devices are vital in the continued improvement in surgical approaches. as with all energy based technologies there are risks. it is important to follow the defined instructions for use when handling these devices after they are activated. use caution and best practices as these devices generate heat. ensure the jaws of your energy based vessel sealing devices are not in contact with unintended tissue surfaces or objects until the jaws have cooled sufficiently. if the jaws are still hot there is a risk that a patient could be unintentionally burned if they have not cooled sufficiently. always refer to a device's operator's manual and instructions for use for proper use and warnings.

Device

ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Modèle / numéro de série
    Model Catalog: 60-9511-001 (Lot serial: All Lots); Model Catalog: 60-9512-001 (Lot serial: All Lots); Model Catalog: 60-9520-001 (Lot serial: All Lots); Model Catalog: 60-9521-001 (Lot serial: All Lots); Model Catalog: 60-9522-001 (Lot serial: All Lots); Model Catalog: 60-9510-001 (Lot serial: All Lots)
  • Description du dispositif
    ALTRUS THERMAL TISSUE FUSION SYSTEM - HANDPIECE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    HC