Events

Retiro De Equipo (Recall) de Device Recall Covidien Emprint Ablation System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Covidien Medical Products (Shanghai) Manufacturing L.L.C..

¿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
    73438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1187-2016
  • Fecha de inicio del evento
    2016-02-23
  • Fecha de publicación del evento
    2016-03-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144214
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, ablation, microwave and accessories - Product Code NEY
  • Causa
    Medtronic is voluntarily recalling specific item codes and production lots of covidien emprint" percutaneous antenna with thermosphere" technology due to the potential for the generator to shut down in the precence of high temperature measurements in the emprint" percutaneous antenna.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter dated February 23, 2016 to all affected customers via Federal Express or Certified Mail. The letter identified the affected product, problem and actions. Customers were advised to quarantine and discontinue use of the affected product and to Return product. For questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.

Device

Device Recall Covidien Emprint Ablation System
  • Modelo / Serial
    Model Numbers: CA15L1, CA20L1 and CA30L1
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide, VA/govt/military consignees.
  • Descripción del producto
    Short Percutaneous Antenna with Thermosphere" Technology || Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. || Long Percutaneous Antenna with Thermosphere" Technology || Product Usage: || The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
  • Manufacturer
    Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Manufacturer

Covidien Medical Products (Shanghai) Manufacturing L.L.C.
  • Dirección del fabricante
    Covidien Medical Products (Shanghai) Manufacturing L.L.C., Building 10 789 Puxinglu, Pujiang, Minhang, Shanghaishi China
  • 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
    USFDA