Events

Alerte De Sécurité sur uretero-reno videoscopes and uretero-reno fiberscopes

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
    2017-01-09
  • Date de publication de l'événement
    2017-01-09
  • 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_20170109a.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 uretero-reno videoscopes and uretero-reno fiberscopes medical device manufacturer, olympus, has issued medical device safety alerts concerning its uretero-reno videoscopes (model numbers: urf-v2 and urf-v2r) and uretero-reno fiberscopes (model numbers: urf-p6 and uf- p6r). for uretero-reno videoscopes, the manufacturer has initiated a corrective action following investigation of customer complaints regarding the breakage of the urf-v2/v2r insertion tube bending section during surgical procedures. to date, some of these complaints are associated with tissue trauma (including one complaint of perforation, and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed). for uretero-reno fiberscopes, the manufacturer has received complaints on the urf-p6/p6r insertion tube, and breaks of the bending tube, but these complaints have not resulted in any known adverse events. the manufacturer is aware of adverse event complaints on the urf-v2/v2r endoscopes which have a similar structure to the urfp6/p6r endoscopes. the manufacturer advises customers to inspect their inventory for the referenced devices and follow the recommended inspection procedures listed in the “instruction for safe use”. 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 9 january 2017.

Device

uretero-reno videoscopes and uretero-reno fiberscopes
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Olympus Uretero-reno Videoscopes and Uretero-reno Fiberscopes
  • Manufacturer
    Olympus

Manufacturer

Olympus