Events

Retiro De Equipo (Recall) de Device Recall Electrosurgical Cutting and Coagulation Device

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 Terumo Cardiovascular Systems Corporation.

¿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
    67193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1069-2014
  • Fecha de inicio del evento
    2013-12-12
  • Fecha de publicación del evento
    2014-02-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124916
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Sterility of medical devices intended for use in surgical procedures may be compromised.
  • Acción
    Terumo CVS notified afected end users by phone on December 12, 2013 and advised that they had become aware that the sterile packaging barrier was breached in specific lots of VirtuoSaph¿ Plus Endoscopic Vessel Harvesting Systems. Customers were requested to return all unused affected product and verify that all users at their institution have been made aware of the risks associated with using the affected devices. For questions call 734-663-4145.

Device

Device Recall Electrosurgical Cutting and Coagulation Device
  • Modelo / Serial
    Lot numbers: 21K, 31K, 32K, 33K, 34K, 35K
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the state of LA, NJ, and NY.
  • Descripción del producto
    VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** || Product Usage: || The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA