Events

Alerte De Sécurité sur Ultrasound Video Endoscopy Evis Exera II, Brand: Olympus, Model GF-UCT-180; Registration: 80124630028, Serial numbers: 1511308,1511310,1110516, 1311111, 1100184, 1110285, 1110490, 1110518, 1411230, 1411254, 1411252, 1411267, 1411270, 1411271, 1411293.

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
    1765
  • Date
    2015-12-02
  • 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
    Olympus Optical of Brazil evaluates that there is at present no indication of changes in product safety and efficacy levels, however, as a risk preventive action, it is contacting its customers and distributing the revised operating manuals. Reprocessing instructions are an important part of the safe use of the product. There is a potential safety concern regarding instructions for using the MAJ-350 cleaning adapter and adding the MAJ-675 and MAJ-1534 to the list of reprocessable and reusable parts and accessories. In case MAJ-350 is not used for reprocessing, the following accessories a) suction cleaning adapter and / or b) the channel plug do not connect to the endoscope, the user would easily notice an error. Based on this, the manufacturer evaluates that the products have most likely been properly reprocessed by users.
  • Cause
    The manufacturer has reviewed the operations manual and identified insufficient information for the use of certain cleaning accessories and reprocessing materials.
  • Action
    The registry holder will review the GF-UCT180 Operation Manual (version RC3242 01) and send an alert message communicating all changes and distributing the revised operating manuals. Olympus asks users to inspect their manual stock and discard any existing stock in the GF-UCT180 Operation Manual and to ensure that all reprocessing personnel are following all steps in the Operation Manual. Action code: FA_148_01_GF-UCT180.

Device

Ultrasound Video Endoscopy Evis Exera II, Brand: Olympus, Model GF-UCT-180; Registration: 8012463...

Manufacturer

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