Events

Alerte De Sécurité sur Trade name: GDC 360 °. Registration number ANVISA: 80005430270. Class of risk: IV - Maximum risk. Affected models / lots: - Model: M0033471020SR0, lots: 17328407, 17581672, 18617200; - Model: M00334811300, lots: 17735100, 17818842.

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 Stryker do Brasil Ltda; Stryker Neurovascular - Business and Technology Park.

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
    1912
  • Date
    2016-04-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    There is no increased risk for users or patients. The most likely effect of incorrect DFU placement on the box is customer dissatisfaction. The most serious clinical effect for the patient is insignificant, which is the prolongation of the procedure. If the physician were to check the DFU for additional information and view the GDC DFU instead of the GDC 360 DFU, it is likely that another device will be used or the procedure will be prolonged.
  • Cause
    There is a potential risk that the gdc 360 springs, from the referenced batches, have been packaged together with the incorrect use statement (dfu). this discrepancy affected only these products. products affected by this field action were correctly labeled (product name, size and etc.). given this, the indications of use, instructions, device function, precautions and precautions associated with the use of the device for the gdc is equivalent to the gdc 360, there are no predictable factors that contribute to product risks. the gdc and gdc 360 springs have the same intended use, the same warnings and precautions, and even mode of operation. the difference is in the name and referring to the shape of the spring. the choice of spring is based on the physician's preference. there are no specific instructions in the dfu (instruction of use) regarding the selection of spring shape or use. the label on the packaging is correct and is the main source of information for choosing the device including the size of the device and shape. the device is intact and expected performance as well. there is no increased risk for users or patients. the most likely effect of incorrect dfu placement on the box is customer dissatisfaction. the most serious clinical effect for the patient is insignificant, which is the prolongation of the procedure. if the physician were to check the dfu for additional information and view the gdc dfu instead of the gdc 360 dfu, it is likely that another device will be used or the procedure will be prolonged.
  • Action
    Distributors of affected lots should, according to the company Stryker do Brasil Ltda - CNPJ 02.966.317 / 0001-02, "print out and adapt the DFU (Instructions for Use) before distributing this item. It is not necessary to return this item to Stryker. "Correction of Instructions for Use Code RA2016-036

Device

Trade name: GDC 360 °. Registration number ANVISA: 80005430270. Class of risk: IV - Maximum risk....

Manufacturer

Stryker do Brasil Ltda; Stryker Neurovascular - Business and Technology Park
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    ANVSANVISA