Alerte De Sécurité sur Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 80124630193 Hazard Class: II Model Affected: URF-P6 / P6R Series Affected: 2613119,2613237,2613239,2612933,2612936,2612947,2112H189,2613101, 2612937, 2613240, 2613102,2613844,2613861,2613846,2613847,2613848,2613845,2613864,2613866.

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 Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp..

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
    2201
  • Date
    2017-02-15
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • 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
    The customer letter describes the actions that Olympus is taking for this field action and informs the customer of instructions for safe use of the equipment to mitigate all risks.
  • Cause
    Olympus medical systems corporation received customer complaints regarding the use of urf-v2 / v2r (not registered in brazil) there were reported 4 adverse events reported in the following countries: france / usa / canada / japan, all urf- v2 / v2r. due to the great similarity with the product urf-p6 / p6r (registered in brazil), it was determined that action was also for this model. the root cause was associated with rupture of the flexible tip, a rupture associated with unsafe use in the patient.
  • Action
    Field Action Code FA_148_05 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Manufacturer