Events

Alerte De Sécurité sur VIDEODUODENOSCOPE, model TJF-Q180V, registration 80124630021, risk class II, various batches / series 2101238, 2101449, 2101548, 2101553, 2101599, 2101631, 2101831, 2202550, 2202634, 2203238, 2203353, 2203354, 2203356, 2303564, 2303904, 2303905 , 2303982, 2304251, 2304251, 2304485, 2304485, 2304485, 2304485, 2404994, 2405413, 2405415, 2405420, 2405423, 2405753, 2505982, 2505997, 2506057, 2001123, 2101369, 2101345, 2101598, 2101600, 2404998, 2505898, 2505892, 2506636, 2506609, 2507086 , 2507076, 2507023, 2506640, 2507137, 2507120, 2507134, 2507122.

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
    1829
  • Date
    2016-03-03
  • 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
    On 04/4/2016 - UPDATE: Users must comply with the guidelines made by the registration company, complete and return the Response Form, in order that the registration holder can implement the activities provided for in said Field Action.
  • Cause
    Olympus worked with the us food and drug administration (fda) to mitigate the risk of infection following endoscopic ercp procedures that used the tjf-q180v. the fda was concerned about the potential leakage of a patient's fluids or materials through the sealing mechanism, the tweezer lift, and asked olympus to tighten the mechanism. since the launch of the product in question in may 2010, there has been no reported case of an infection occurring after an ercp using the tjf-q180v, due to o-ring leakage from the tweezers lift. however, olympus made the following design upgrades related to the tweezer lift sealing mechanism in order to reduce the chances of a potential leak: a) narrowed dimensional tolerances of the mechanical parts related to the sealing mechanism. b) narrowed dimensional tolerances and hardness for the o-rings. then, the fda approved the "design" changes above. in addition, through communications with the fda, olympus has decided to do so. mainly, the following labeling changes: 1) return the tjf-q180v to an annual inspection of the damaged sealing mechanism at olympus; 2) conduct pre-cleaning and manual cleaning on the tjf-q180v, as instructed in the tjf-q180v reprocessing manual, even when using the endoscopes automatic reprocessor ("aer"), which has instructions that may indicate that the user could fail to perform a few steps in the pre-cleaning and manual cleaning of the endoscopes; 3) the new reprocessing manual is providing instructions for using the new cleaning brush to remove impurities from the elevator recess area.
  • Action
    Action code FA_148_03. Sending of letter- updating of instructions for use and reprocessing, new brush and new design- of 02/03/2016 to customers affected by email and mail //// submit the updated Anvisa registry new instructions for use and reprocessing, adding a new cleaning brush //// Sending all affected customers free disposable cleaning brushes //// Schedule service training for all affected customers on new cleaning procedures //// Sending second letter to schedule the replacement of the lift mechanism for new design. Code FA-148-03

Device

VIDEODUODENOSCOPE, model TJF-Q180V, registration 80124630021, risk class II, various batches / se...

Manufacturer

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