Notificaciones De Seguridad De Campo acerca de DGP-HP RFA High-Power single use grounding pad and Cool-tip RFA Electrode Kits, Cool-tip RF System Electrode kits cluster, Cool-tip RF System Accessories

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Covidien LP.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has decided to implement a safety corrective measure in the field, ie withdrawal of the medical device from use, due to the risk posed on the grounding pad, which leads to degradation of the foil and release unwanted heat that can cause burns in patients. covidien received four reports of serious injuries, that is, burns at the location of the electrode pad. cool-type rf system accessories also contains grounding pads so that there is also the risk of an adverse reaction - burns.


  • Modelo / Serial
    168583 - 213736X, 171281 - 215747X, 168576 - 214355X, 170882 - 214971X, 168571 - 213013X, 169419 - 220740, 168854 - 213368X, 168574 - 214434X, 169684 - 214973, 171300 - 208194X, 168575 - 215632, 168853 - 213703X, 170383 - 213699X, 169683 - 213042X, 169683 - 213042X, 170384 - 215746X, 184240 - 205456, 177906 - 214357X, 191404 - 205455, 162732 - 214867X
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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