Events

Avis De Sécurité sur ECHO-HD-22-EBUS-O, ECHO-HD-25-EBUS-O

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 Cook Medical Europe.

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
  • Date
    2015-11-25
  • 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
    Cook ireland ltd is in the process of updating its ifu0051 instruction manual (ifu0051) from revision 5 to revision 6 to enter text concerning the endobronchial ultrasound needle of the echotip® ultra-high resolution, “this product is for single use only. any attempt at recovery, sterilization and / or reuse may result in product failure and / or transfer diseases, as the aforementioned text was omitted in revision 5 of these operating instructions. this statement was included in a previous revision of the package leaflet and is intended for customers who have not previously received a product and are therefore not aware of the risks of reusing this product as required by mdd 93/42 / ec.

Device

ECHO-HD-22-EBUS-O, ECHO-HD-25-EBUS-O

Manufacturer

Cook Medical Europe