Events

Alerta De Seguridad para Offset Cup Impactor Universal

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

¿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
    2017-02-06
  • Fecha de publicación del evento
    2017-02-06
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170206b.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: brainlab offset cup impactor universal medical device manufacturer, brainlab, has issued a medical device safety alert concerning its offset cup impactor universal [product reference: article number 52856/52856a]. the manufacturer identified that when the affected product (blue handle) is reprocessed in a sterilization tray as described in the current brainlab cleaning, disinfection and sterilization guide (revision 5.2 and previous) the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 can only be achieved if the device is individually wrapped for sterilization. according to the manufacturer, if a non-sterile affected product is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to infection. the manufacturer advises users are to follow the updated sterilization instructions (bl-il-60960-69ml rev. 1) to achieve the required sterility assurance level (sal) of 10-6. 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 06 february 2017.

Device

Offset Cup Impactor Universal
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Brainlab Offset Cup Impactor Universal
  • Manufacturer
    Brainlab

Manufacturer

Brainlab