Events

Alerte De Sécurité sur Commercial Name: Videoduodenoscopes // Registration Number Anvisa: 10371280029 // Risk Class: II Medium Risk // Model Affected: ED-3490TK // Serial Number Affected: H110761, H110763 and H110765

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 Pentax Medical Brasil Materiais e Equipamentos Ltda; HOYA CORPORATION PENTAX MIYAGI FACTORY.

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
    1828
  • Date
    2016-03-09
  • 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
    The company that registers in Brazil notes: "It is recommended that all users of Pentax ED-3490TK videoduodenoscopes follow strictly the new instructions and procedures for high-level cleaning and disinfection included in the reprocessing and up-to-date operation manual. The updated reprocessing manual should be fully read by users and any questions or concerns should be immediately forwarded to Pentax Medical Brazil, its field technicians and / or regulatory affairs department, to ensure that all recommendations are clearly understood and in this way reduce the risk of contamination during ERCP / ERCP procedures. "
  • Cause
    In 2015 the fda issued a public safety notice informing of the potential association between duodenoscopes and incident reports on ercp cholangiopancreatography procedures associated with the presence of multiresistant bacteria in patients undergoing this procedure in a few institutions in the united states. since then pentax in conjunction with the fda, medical societies and healthcare professionals, has updated and validated reprocessing instructions for the ed-3490tk duodenoscope model.
  • Action
    After learning of these adverse events and the FDA safety communication, to inform health professionals about the potential association between duodenoscopes and incident reports during ERCP / ERCP in some hospitals in the United States, Pentax has been working with the FDA, as part of an industry initiative to determine what additional steps, if necessary, could be taken to reduce the risk of infection in flexible endoscopes used for ERCP / ERCP. Pentax has conducted tests to increase the safety margin associated with reprocessing of the ED-3490TK duodenoscope. In Brazil on 12/8/2015 Pentax Medical Brazil responded to Anvisa notification No.79 / 2015 / GEAAR / GGMON / ANVISA, indicating that upon completion of these tests it could provide a new reprocessing manual and instructions for all who purchased the duodenoscope Pentax model ED-3490TK. Field actions involve the following procedures: 1- Translate the new Pentax reprocessing and operation manual into Portuguese. 2- Communicate and send to all users of the ED-3490TK, the new reprocessing and operation manual, containing the new instructions for use, reprocessing, cleaning, disinfection and sterilization. 3- Perform reprocessing and cleaning training for all users who have purchased the ED-3490TK to ensure these instructions are understood.

Device

Commercial Name: Videoduodenoscopes // Registration Number Anvisa: 10371280029 // Risk Class: II ...

Manufacturer

Pentax Medical Brasil Materiais e Equipamentos Ltda; HOYA CORPORATION PENTAX MIYAGI FACTORY
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    ANVSANVISA