Events

Alerte De Sécurité sur Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer

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

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
    2012-12-04
  • Date de publication de l'événement
    2012-12-04
  • 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_20121204.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: ethicon endo-surgery enseal g2 curved and straight tissue sealer the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning enseal g2 curved and straight tissue sealer, manufactured by ethicon endo-surgery (ees). the affected products could be identified by the following product codes: nslg2c14, nslg2c25, nslg2c35, nslg2c45, nslg2s14, nslg2s25, nslg2s35, nslg2s45. all lot numbers with expiration date from october 2013 through september 2017 are impacted. according to the manufacturer, there is a potential for self-activation while the device is in use, which could result in injury to patients or users (thermal damage). to date, the manufacturer has not received any reports of patient or user injuries. the manufacturer advises all affected users to stop immediately the use of ees enseal g2 curved and straight tissue sealer. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con208680 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 december 2012.

Device

Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ethicon Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
  • Manufacturer
    Ethicon Endo-Surgery

Manufacturer

Ethicon Endo-Surgery