Events

Rappel de Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used with microwave generator for coagulation of soft tissue)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien 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-00210-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-02-26
  • 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-00210-1
  • 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
    This recall is being conducted following customer reports of the emprint ablation generator shutting down due high temperature measurements in the emprint percutaneous antenna.If the generator shuts down due to elevated temperature readings at the antenna tip, the antenna must be replaced and the ability to tract ablate is limited. antenna replacement can result in a delay in treatment or the inability to treat and increases the risk of bleeding and, in the case of lung procedures, the occurrence of pneumothorax. there have been no reports of serious injury associated with this recall.
  • Action
    Covidien is advising users to quarantine and discontinue use of the affected units. Covidien will arrange for the recovery of these units and the issuance of credit to the affected customers.

Device

Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used...
  • Modèle / numéro de série
    Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used with microwave generator for coagulation of soft tissue)Item codes: CA15L1, CA20L1, CA30L1Multiple lot numbers affectedARTG number: 178369
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA