Events

Alerte De Sécurité sur visera elite ii video system center olympus otv-s200 and otv-s300

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
    2018-06-21
  • Date de publication de l'événement
    2018-06-21
  • 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_20180621.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: visera elite ii video system center olympus otv-s200 and otv-s300 medical device manufacturer, olympus, has issued a medical device safety alert concerning its visera elite ii video system center olympus otv-s200 and otv-s300 [serial number: 7700172, 7700627, 7700628, 7700734, 7700768, 7700899 and 7700901]. during the manufacturing process of the products, an unintended power shut down was noticed during a routine quality test. the failure has temperature dependency and may occur under environment of normal usage. therefore, it has decided to replace the power supply unit of the affected products with redesigned parts. according to the manufacturer, the products are surgical systems that are assumed to be used under environmental temperatures lower than twenty-five degrees celsius (25°c), the probability of remarkable declined exhaust heat efficiency due to dust accumulation is low and it is confirmed that operation of power supply will maintain its function unless the deterioration of the component is considerably advanced. therefore, the manufacturer surmised that the chance of occurrence for the power supply failure in the short term period is very low. there is no incidence of power shut down or patient injury has been reported during clinical usages so far. the manufacturer will contact the affected users and implement the corrective action plan to replace the power supply. the affected users can continue the usage of the products but, at the same time, it is recommended that another camera system be always kept as a standby. 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 21 june 2018.

Device

visera elite ii video system center olympus otv-s200 and otv-s300
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200 and OTV-S300
  • Manufacturer
    Olympus

Manufacturer

Olympus