Events

Alerte De Sécurité sur Anaconda ONE- LOK Bifurcate Body and Anaconda Bifurcate Body

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Vascutek Ltd.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-10-22
  • Date de publication de l'événement
    2013-10-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131022.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: terumo anaconda one- lok bifurcate body and anaconda bifurcate body medical device manufacturer, vascutek ltd, a terumo company, has issued a field safety notice concerning anaconda one-lok bifurcate body and anaconda bifurcate body. the affected catalogue numbers are as follows: anaconda one-lok bifurcate body: olb21, olb23, olb25, olb28, olb30, olb32, olb34 anaconda bifurcate body: b19, b21, b23, b25, b28, b30, b32, b34 vascutek ltd has received three complaints (with an occurrence rate of 0.1%) where the release wire of an anaconda body delivery system has fractured following stent deployment. two of these three incidents resulted in conversion to open repair. the voluntary recall addresses potential risks associated with the wire fracturing and the possibility of conversion to open repair. according to the manufacturer, this is a potential failure mode of to delivery system and does not affect the safety or efficacy of the implantable stent. previously implanted stents are not affected by this voluntary recall. furthermore, according to the manufacturer, there is no suggestion that patients already implanted with anaconda one- lok bifurcate body or anaconda bifuracte body are exposted to any raised level of risk. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 october 2013.

Device

Anaconda ONE- LOK Bifurcate Body and Anaconda Bifurcate Body
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Anaconda ONE- LOK Bifurcate Body and Anaconda Bifurcate Body
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd