Events

Alerta De Seguridad para Soft Tissue Retractor, small, extendible

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

¿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
    2013-05-08
  • Fecha de publicación del evento
    2013-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508d.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 soft tissue retractor, small, extendible medical device manufacturer, synthes gmbh, has issued a field safety notice concerning soft tissue retractor, small, extendible with part number 325.101. synthes received complaints about tip breakage/locking nut malfunction. retrieval of device fragments intraoperatively and delayed surgical procedure have been reported as a result of locking nut malfunction. unretrieved device fragments may result in an adverse tissue reaction, complaint events have been reported that required the removal of generated device fragments. no known adverse tissue reactions have been reported due to the presence of unretrieved device fragments. surgical delays have been reported due to device failure and the resulting time required for retrieving the device fragments. besides, the sudden loss of function, intraoperative breakage, of the soft tissue retractor has the potential to result in soft tissue irritation. according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 08 may 2013.

Device

Soft Tissue Retractor, small, extendible
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Soft Tissue Retractor, small, extendible
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH