Events

Retiro De Equipo (Recall) de ULTIMA OPCAB 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 Maquet Cardiovascular, 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
    66365
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0001-2014
  • Fecha de inicio del evento
    2013-09-20
  • Fecha de publicación del evento
    2013-10-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122158
  • 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
    Cardiovascular surgical instruments tray (kit) - Product Code OFA
  • Causa
    Maquet has identified a potential issue with the ultima opcab (part numbers om-2003s & om-2001d). labeling for the 2 blade lots had been incorrectly applied. the standard blades from lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from lot #25052200 were incorrectly labeled as standard blades.
  • Acción
    MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; informs the customers of the nature of the issue; and advises of potential adverse patient consequences that may occur. The customer is asked to complete and return the Field Recall Response Form. If the customer has questions they are directed to contact their field representative or MAQUET Technical Support (888.627.8383 between 8 am and 5 pm EST Monday through Friday).

Device

ULTIMA OPCAB System
  • Modelo / Serial
    ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200).
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of: Florida, Maryland, New Jersey, New York and Texas.
  • Descripción del producto
    Ultima OPCAB System, Sterile, Rx Only, || Product Usage: || Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Dirección del fabricante
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA