Events

Avis De Sécurité sur OLYMPUS TJF‐145 DUODENOSCOPE

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Olympus.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Olympus xx is writing to inform you that we are issuing validated, new reprocessing instructions for the olympus tjf‐145 duodenoscope, consisting of revised manual cleaning and disinfection procedures to increase the safety margin against infection after ercp using the tjf‐145. these new reprocessing procedures should be implemented as soon as possible. the new cleaning procedure requires the use of a new cleaning brush (maj‐1534), which is enclosed with this letter. after the enclosed brushes are consumed, the brushes will be available for purchase in sufficient quantities to meet your facility’s needs through our normal sales order process. please note the maj‐1534 brush is a reusable brush, which can be sterilized by autoclave following use. instructions for sterilizing the maj‐1534 brush can be found in the enclosed, new reprocessing manual. .

Device

OLYMPUS TJF‐145 DUODENOSCOPE
  • Modèle / numéro de série
  • Manufacturer
    Olympus

Manufacturer

Olympus