Events

Alerte De Sécurité sur Videoduodenoscope, Brand: Olympus, Record: 80124630021, Serial numbers: SEE ANNEX.

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 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
    1538
  • Date
    2015-03-11
  • 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 the company, there are no cases reported in Brazil of infection associated with the use of this endoscope and no indication of changes in levels of safety and efficacy of the product. The alert has the preventive character.
  • Cause
    Alert about the association of duodenoscope use and presence of infection after performing the procedure with this equipment. the complaints that have arisen are of occurrences located in the united states. the reported infections are caused by carbapenen-resistant enterobacteria (ckd) in which drug treatment is limited to few antibiotics.
  • Action
    The registrant guides reprocessing of the endoscope through high-level disinfection and the process must be performed according to the manufacturer's recommendations. Failure to follow pre-cleaning instructions, leak testing, manual cleaning and disinfection or sterilization has the potential of cross-contamination and risk of infection. The orientation is for customers to ensure that the reprocessing team is aware and trained to perform the procedures in accordance with the instructions in the manual. In addition, the team is advised to inspect the equipment before use by evaluating the presence of stains or improper cleaning and, in such cases, re-reprocessing. It is important to report the occurrence of cases of infection and persistent bacterial colonization associated with the use of the Olympus endoscope. Any other guidance or training request the company is available to contact.

Device

Videoduodenoscope, Brand: Olympus, Record: 80124630021, Serial numbers: SEE ANNEX.

Manufacturer

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