Events

Avis De Sécurité sur OLYMPUS ENDOEYE HD II Video Telescope

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 has initiated this removal action following a complaint of a damaged temperature sensor at the endoeye tip which caused the distal end to become abnormally hot. although no patient or user injury occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury. in an effort to prevent a potential risk to patient or user health, olympus is undertaking this action to remove the model and serial numbers identified above and to repair and return the devices. the repair to correct this problem will not be available until january 2016. however, we are requiring the return of your affected devices now so as to disable a feature on the video telescopes (“fog free”) which will prevent excessive heating of the endoeye distal end. once the repair parts are available in january 2016, we will contact you again for return of your devices for the permanent corrective action. .

Device

OLYMPUS ENDOEYE HD II Video Telescope
  • Modèle / numéro de série
    WA50040A, WA50042A
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS