Events

Retiro De Equipo (Recall) de EEA DST Circular Anastomosis Stapler

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Covidien France SAS.

¿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
  • Fecha
    2008-03-31
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-agrafeuses-pour-anastomose-circulaire-eea-dst-de-diametre-25-mm-28-mm-31-mm-societe-covidien-france-sas
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On March 26, 2008, Covidien France SAS has withdrawn from the market all batches that do not end with the letter H of the references contained in the enclosed message of the medical device called EEA DST Circular Anastomosis Stapler for Diameter 25 mm , 28 mm, 31 mm, manufactured by United States Surgical, following materovigilance reports related to the use of these medical devices resulting in postoperative latencies. Covidien France SAS has directly notified the recipients of the incriminated lots with the enclosed message (26/03/2008) (29 KB) validated by Afssaps. This information is addressed to the correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned are informed of this measure by Afssaps.

Device

EEA DST Circular Anastomosis Stapler

Manufacturer

Covidien France SAS
  • 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
    LAANSM