Events

Alerte De Sécurité sur ENDOEYE HD II Video Telescope

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Olympus.

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
  • Date
    2017-02-06
  • Date de publication de l'événement
    2017-02-06
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170206a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: olympus endoeye hd ii video telescope medical device manufacturer, olympus, has issued a medical device safety alert concerning its endoeye hd ii video telescope [product code: w wa50040a and wa50042a; serial number: all]. the manufacturer has initiated this fsca after discovering that the endoeye distal end can become abnormally hot if the temperature sensor at the device’s tip is damaged. although no customer complaints have been received referring to this issue and thus no patient or user injury has occurred, 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, the manufacturer is undertaking the action to remove the model and serial numbers identified above and to modify and return the devices. according to the manufacturer, disabling a specific feature on the video telescope (i.E. fog-free function) will prevent excessive heating of the endoeye distal end in case of certain faults. the manufacturer will provide an addendum to the instructions for use with the modified devices. affected users are advised to take the following actions:- inspect the inventory for the captioned devices and discontinue use of any affected devices. return the affected devices for modification. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2017.

Device

ENDOEYE HD II Video Telescope
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Olympus ENDOEYE HD II Video Telescope
  • Manufacturer
    Olympus

Manufacturer

Olympus