Events

Alerte De Sécurité sur GlideScope Reusable GVL and AVL Blades

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

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
    2013-05-27
  • Date de publication de l'événement
    2013-05-27
  • 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_20130527.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: verathon glidescope reusable gvl and avl blades medical device manufacturer, verathon, has issued a field safety notice concerning glidescope reusable gvl and avl blades. the affected blades are provided with specific “builds” of the glidescope video laryngoscope, model numbers gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; and agvl 2 074-0118, agvl 3 0574-0115, agvl 4 0574-0116, and agvl 5 0574-0117. these blades were manufactured between august 2011 and june 2012. this safety alert does not apply to ranger blades or single use systems, including video batons and stats. in blades built, verathon has identified a possible flaw induced along the seams of the plastic blades as a result of using a handheld plasma torch to clean the seam surfaces and camera location before bonding. during its operation to generate a plasma bond, the handheld plasma torch produced a localized intense heating of the plastic to a high temperature. that inadvertent spot heating of the plastic at the seam and the camera location induced unintended localized stress into the area surrounding the seam and camera. verathon has become aware of several patient incidents of a fracture/breakage of the laryngoscope blade resulting in a detached piece remaining in the patient airway requiring medical intervention to remove the component. the manufacturer advises customers to discontinue use of these products and to return the products to the manufacturer. if you are in possession of the products, please contact your supplier for necessary actions. posted on 27 may 2013.

Device

GlideScope Reusable GVL and AVL Blades
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Verathon GlideScope Reusable GVL and AVL Blades
  • Manufacturer
    Verathon

Manufacturer

Verathon