Events

Alerte De Sécurité sur Pentax Bronchoscope

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 Precision Instrument Corporation.

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
    766
  • Date
    2004-03-01
  • 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
    Brazil - 01.03.2004 - The Technovigilance Unit / GGTPS / ANVISA has initiated an investigation to verify that similar events are occurring at the national level.
  • Cause
    Six cases of contamination of pentax bronchoscopes by strains of pseudomonas aeruginosa and / or maltophilia were reported to afssaps in france between june 18 and august 6, 2003. the bacteriological examination performed on these bronchoscopes by an independent laboratory and the analysis conducted by the scientists from afssaps have been able to identify: on the one hand the existence of non-compliance with the recommendations on cleaning procedures for decontamination, and on the other hand a defect in the design of the device at the level of the entrance of the channel for operations. in january 2004, 17 positive tests were reported to afssaps by 10 health facilities.
  • Action
    On September 17, 2003, the company Pentax informed the user centers of the start of the validity of a technical change in this part located at the entrance of the channel for operations of the referred endoscopes. At the same time, Afssaps drew users' attention to the importance of complying with Good Disinfection Practices, especially in those services that may use endoscopic devices, and asked them to carry out bacteriological controls of the endoscopes before starting the endoscope with this modification. The bronchoscopes referred to are currently in bacteriological expertise by an independent laboratory.159 of the 472 endoscopes health care facilities contacted Pentax to perform the replacement of the endoscopes in which the tests were negative (408 bronchoscopes). 240 of these endoscopes have already been modified by Pentax. Afssaps reported these data to all health facilities on 6 January 2004 and also recalled the need to contact Pentax quickly to ensure that modification of the endoscopes can be continued as soon as possible.

Device

Pentax Bronchoscope

Manufacturer

Pentax Precision Instrument Corporation
  • Source
    ANVSANVISA