Events

Retiro De Equipo (Recall) de Device Recall Intact Disposable Wands

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
    76130
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1134-2017
  • Fecha de inicio del evento
    2016-12-28
  • Fecha de publicación del evento
    2017-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152257
  • 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
    Instrument, biopsy - Product Code KNW
  • Causa
    Product sterility compromised due to breach of sterile barrier.
  • Acción
    Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.

Device

Device Recall Intact Disposable Wands
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
  • Descripción del producto
    Intact Disposable Wands (part of the Intact System) || 900-130: 5 Pack 30mm Disposable || Product Usage: || The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
  • 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