Events

Retiro De Equipo (Recall) de Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator

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 Medtronic Advanced Energy, LLC.

¿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
    66835
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0905-2014
  • Fecha de inicio del evento
    2013-11-12
  • Fecha de publicación del evento
    2014-01-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123689
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to dc voltage when the device is activated is being compromised during normal use.
  • Acción
    Medtronic sent an Urgent Product Removal Notification on November 12, 2013, via Next Day FEDEX. The communication advises users to immediately stop using the affected AQM3 electrosurgical generators and quarantine them until they can be returned to Medtronic Advanced Energy. Medtronic field personnel will collect them in order to remove them from service and return them to Medtronic Advanced Energy. Customers with questions were instructed to contact Customer Service at 866-777-9400. For questions regarding this recall call 866-777-9400.

Device

Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator
  • Modelo / Serial
    lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
  • Descripción del producto
    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) || The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
  • Manufacturer
    Medtronic Advanced Energy, LLC

Manufacturer

Medtronic Advanced Energy, LLC
  • Dirección del fabricante
    Medtronic Advanced Energy, LLC, 180 International Dr, Portsmouth NH 03801-6837
  • 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