Events

Rappel de Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)

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-2013-RN-00414-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-10
  • 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-00414-1
  • 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
    Covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient's abdominal and thoracic cavity.
  • Action
    Covidien is asking customers to quarantine and discontinue use of all affected lot numbers. Covidien will arrange for pick-up of the affected lots.

Device

Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)
  • Modèle / numéro de série
    Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)Multiple product codes and lot numbers:ONB5LGF (Lots N2K0019X through N3A0294X)ONB5SHF (Lots N2J0265X through N3A0391X)ONB5STF (Lots N2H0353X through N3D0033X)ONB5STF2C (Lots N2J0211X through N3D0118X)ONBFCA5SH (Lots N2J0315X through N3A0389X)ONBFCA5ST (Lots N2J0150X through N3C0683X)ARTG Number: 178557
  • 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