Events

Alerta De Seguridad para Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II

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

¿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
    2016-07-18
  • Fecha de publicación del evento
    2016-07-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160718b.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: synthes adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii medical device manufacturer, synthes, has issued a medical device safety alert concerning the following devices: adapter for colibri for electric pen drive; b) adapter, small, for colibri (ii) and small battery drive (ii) part number: a) 05.001.024 and b) 05.001.108 according to the manufacturer, there is a potential for the adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii to generate excessive internal pressure that may cause the respective products to burst. the captioned device could cause permanent injury to the user and/or patient. although preliminary internal tests for this failure mode have determined this scenario is highly unlikely to occur, the manufacturer has decided to remove these products from the field. 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 18 july 2016.

Device

Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Dr...
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II
  • Manufacturer
    Synthes

Manufacturer

Synthes