Events

Avis De Sécurité sur OLYMPUS ENDOEYE HD II

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 started this [vka / removal procedure] when they found that the distal end of the endoeye could become extremely hot if the temperature sensor at the tip of the device was damaged.   even though we have not received any complaint from this [customer] about this issue - meaning no injury to the patient or user - overheating the distal end of the endoeye may cause injury to the patient or user. we strive to prevent potential patient or user health risks, and we therefore take olympus to [recall / remove] the model and serial numbers listed above, as well as modify and return devices.

Device

OLYMPUS ENDOEYE HD II
  • Modèle / numéro de série
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS