Alerte De Sécurité sur ENDOPROTYPE ANACONDA. Registration ANVISA n ° 80012280090. Models at Risk: Anaconda One-Lok Bifurcated Body and Anaconda Bifurcated Body. Lots under risk: OLB21; OLB23; OLB25; OLB28; OLB30; OLB32; OLB34; B19 * 01; B19 * 02; B21 * 01; B21 * 02; B23 * 01; B23 * 02; B25 * 01; B25 * 02; B25 * 01; B25 * 02; B30 * 01; B30 * 02; B32 * 01; B32 * 02; B34 * 01; B34 * 02 (all batches).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Terumo Medical do Brasil Ltda.; Vascutek Limited Inc..

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
  • ID de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    According to information submitted by Terumo, the manufacturer of the products (Vascutek Ltd) received 3 complaints (with an occurrence rate of 0.1%) reporting anaconda body release system wire fracture. Two of these three incidents resulted in conversion to open chest surgery. Vascutek ltd has initiated a voluntary recall of all anaconda bodies, with root cause identification and implementation of corrective actions ongoing. Voluntary recollection aims to reduce potential risks to the patient associated with wire fracture and the possibility of conversion to open chest surgery. A clinical evaluation was performed for the three adverse events and the high patient safety risk was confirmed by the conversion of the previously minimally invasive open chest surgery. Although the frequency of occurrence is low, the fact that the problem can not be detected during the manufacturing or before the procedure is performed, supports that the recommended action is the collection of the bodies of the market. Users are advised to discontinue use of this product immediately, to block and segregate existing inventory and to return it to terumo medical do brasil ltda. The company will return the items to the manufacturer. Prosthetics already implanted are not affected by this recall, since the problem is restricted to the delivery system. The retreat does not extend to the iliac branch anaconda, broad iliac branch or aortic extension. For more detailed information, consult the Alert Message of the company at: #### Update on 08/27/2014: the field action was completed by the company on 02/11/2014, as informed to Anvisa (08/13/2014). 413 units were collected from a total of 910 units at risk in Brazil.
  • Cause
    Possibility of fracture of the wire of the system of liberation of the body of the device anaconda.
  • Action
    Terumo is collecting the products at risk. Discontinue use of the product immediately. Identify, lock and segregate existing inventory to avoid inadvertent use.