Events

Alerte De Sécurité sur VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Products affected: all serial numbers belonging to the codes (product codes) described in the annex http://portal.anvisa.gov.br/wps/wcm/connect/f933b60048c63f1dae8eafa3f2835ae8/Alerta_1097_Carta_aos_clientes.pdf? MOD = AJPERES.

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.

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
    1097
  • Date
    2011-10-21
  • 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
    According to information received by the UTVIG, there are 25 units potentially affected by the problem in Brazil. In its risk assessment for the case, the company has presented some potential hazards and damages that may result from nonconforming installations: loss of video signal, non-operation of the failure latches and overheating of light cranks (which may system components, such as flexible arms, surgical lights, flat panels, etc.). According to the company, the probability of occurrence of such events is remote and no related adverse events have been reported to the company so far. #### UPDATE - 10/01/2012 - The company forwarded file 0037019 / 12-3 , where he reports the completion of the field action, and all clients were informed. ####
  • Cause
    Documentation regarding product installations is incomplete or inadequate.
  • Action
    Stryker do Brasil Ltda reported that it has already begun to communicate to customers who own the equipment. Health care facilities that have affected equipment should schedule an inspection with Stryker, to verify the situation of the equipment installed and to prepare appropriate documentation.

Device

VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Products affected: all seri...

Manufacturer

Stryker do Brasil Ltda
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    ANVSANVISA