Events

Alerte De Sécurité sur Modulith SLX-F2

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

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
    2016-03-01
  • Date de publication de l'événement
    2016-03-01
  • 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_20160301.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: storz medical modulith slx-f2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning modulith slx-f2 manufactured by storz medical. the affected serial numbers are 0r.079, 0r.269, 0r.110 and 0r.299. the system includes a table insert from carbon fibre as part of the optional urology kit. the manufacturer has observed that due to the addition of tolerances of the table insert and the table cutout, the table insert can slip out of place. during patient treatment the slipping of the insert plate can lead to a sudden downward movement of the patient. according to the manufacturer, this patient movement will be compensated by the patient foil after a few centimeters. nevertheless, if at this moment an endoscopic instrument is inserted into the patient, serious injury may occur. to prevent the risk of injuries, the manufacturer advises that user must make sure that the lithotripter is no longer operated in combination with the actual carbon fibre insert plate. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-22-february-to-26-february-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 march 2016.

Device

Modulith SLX-F2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Storz Medical Modulith SLX-F2
  • Manufacturer
    Storz Medical

Manufacturer

Storz Medical