Events

Retiro De Equipo (Recall) de Device Recall Nico Myriad

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 Nico Corp..

¿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
    72015
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2767-2015
  • Fecha de inicio del evento
    2015-07-29
  • Fecha de publicación del evento
    2015-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139582
  • 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
    Motor, surgical instrument, ac-powered - Product Code GEY
  • Causa
    Two cables within the console were inadvertently twisted during manufacturing. the individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. when these wires break or contact one another (i.E., short), various types of malfunction may occur with the console. one type of malfunction may result in unexpected aspiration increase.
  • Acción
    The firm, Nico Corporation, sent an "URGENT: NICO Console Recall" notification dated 7/31/15 via fax to its customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to return the console and complete and return the Recall Response Form via fax to: 317-683-0305 or email to: Jay.Dittman@niconeuro.com. The firm will provide customers with a Myriad Console loaner kit. If you have any questions, contact Director of Quality and Regulatory, at 317-660-7118 ext 104 or email to: jay.dittman@nicneuro.com.

Device

Device Recall Nico Myriad
  • Modelo / Serial
    Model number NN-7000  SN: 00231, 00232, 00242, 00245, 00248, 00250
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: MD, IN, CA, and NC.
  • Descripción del producto
    NICO Myriad Console || Model number NN-7000 || The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. || For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
  • Manufacturer
    Nico Corp.

Manufacturer

Nico Corp.
  • Dirección del fabricante
    Nico Corp., 250 E 96th St, ste 125, Indianapolis IN 46240-3781
  • Empresa matriz del fabricante (2017)
    NICO Corp
  • Source
    USFDA