Events

Alerta De Seguridad para Modulith SLX-F2

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Storz Medical.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2016-03-01
  • Fecha de publicación del evento
    2016-03-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160301.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Storz Medical Modulith SLX-F2
  • Manufacturer
    Storz Medical

Manufacturer

Storz Medical