Events

Retiro De Equipo (Recall) de Surgical stitching instruments with cassettes and interchangeable jaws for open and endoscopic surgical interventions

Según Federal Service for Surveillance in Healthcare, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Russian Federation que fue producido por Kovidien Lls,.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    01И-242/16,
  • Fecha
    2016-02-10
  • Fecha de publicación del evento
    2016-02-11
  • País del evento
    Russian Federation
  • Fuente del evento
    FSSH
  • URL de la fuente del evento
    http://www.roszdravnadzor.ru/services/unreg
  • Notas / Alertas
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 recall data from the U.S. and Russia.
  • Notas adicionales en la data
    Manufacturer Recall

Device

Surgical stitching instruments with cassettes and interchangeable jaws for open and endoscopic su...

Manufacturer

Kovidien Lls,
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    FSSH