Events

Alerta De Seguridad para HARMONIC ACE+ 7 Shears

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

¿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
    2015-10-07
  • Fecha de publicación del evento
    2015-10-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151007b.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: ethicon harmonic ace+ 7 shears medical device manufacturer, ethicon, has issued a medical device safety alert concerning its harmonic ace+ 7 shears [product code: harh23, harh36, harh45]. the manufacturer is initiating a global voluntary recall (removal) of the harmonic ace+ 7 shears (harh23, harh36, harh45) because under extreme handling circumstances, damage, such as a hole, can occur in the tyvek lid due to an interaction between the advanced hemostasis (green) button and the tyvek lid which could compromise device sterility. the manufacturer has received no reports of adverse events for this issue and this recall does not relate to the functionality of the device. affected users are advised to use alternative product while waiting for replacement. 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 7 october 2015.

Device

HARMONIC ACE+ 7 Shears
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Ethicon HARMONIC ACE+ 7 Shears
  • Manufacturer
    Ethicon

Manufacturer

Ethicon