Events

Alerte De Sécurité sur Trade name: Ureterorenofibroscope. Technical Name: Ureterorenofibroscope. ANVISA registration number: 80124630193. Class of risk: II. Model affected: URF-P6 / P6R. Affected serial numbers: 2613119, 2613237,2613239, 2612933, 2612936, 2612947, 261H189,2613101, 2612937, 2613240, 2613102, 2613844, 2613861, 2613846, 2613847, 2613848, 2613845, 2613864, 2613866, 2612931, 2613077, 2613843.

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
    2545
  • Date
    2018-04-17
  • 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
    1. Inspect your inventory and identify any URF-P6 / P6R models. 2. Olympus Optical do Brasil Ltda will contact your facility to make arrangements to return your URF-P6 / P6R uretero-rene fibroscope (s), as well as for the subsequent device exchange. You will receive instructions on how to return the URF-P6 / P6R for this exchange. 3. If you are a business partner and have distributed the URF-P6 / P6R, please identify your customers, notify them immediately of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 4. Please indicate in the attached questionnaire that you received this notification. Additionally, please fill in the affected URF-P6 / P6R number in your inventory. E-mail the complete form to [calidad.brasil@olympus.com]. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Cause
    Olympus received 7 customer complaints about urf-v2 / v2r endoscopes associated with tissue trauma (3 cases), ureter perforation (1 case), and insertion tubes that were stuck inside the patient and had to be surgically removed ( 3 cases). research has shown that breaking within the underlying metal bending tube of the endoscope contributes to adverse events. olympus has modified the curvature mechanism. in an effort to mitigate the occurrence of adverse events, olympus initiated this action by fsca to replace existing products with those with the new curvature mechanism. in addition, for urf-p6 / p6r endoscopes, there were no adverse events associated with curvature section breaking. however, urf-p6 / p6r has a similar but not identical design to urf-v2 / v2r. therefore, in an effort to mitigate the occurrence of adverse events, omsc decided to undertake the same action for urf-p6 / p6r as urf-v2 / v2r.
  • Action
    Field Action Code FA_150_02 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Collection and exchange of impacted unit.

Device

Trade name: Ureterorenofibroscope. Technical Name: Ureterorenofibroscope. ANVISA registration num...

Manufacturer

Olympus Optical do Brasil Ltda; Olympus Medical Systems Corp.