Events

Retiro De Equipo (Recall) de Device Recall VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE 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 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
    57735
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1230-2011
  • Fecha de inicio del evento
    2011-01-10
  • Fecha de publicación del evento
    2011-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97290
  • 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 &38; plastic surgery - Product Code GCJ
  • Causa
    The bipolar cord product specification indicates the product has a service life of 50 uses. however the ifu does not specify an end of service life. the firm has recieved 46 complaints on the bipolar cord. the firm investigated and found that the units involved in the complaints were often over 12 months old. the firm believes the units involved in the complaints were beyond their product life.
  • Acción
    Terumo Cardiovascular Systems Corporation sent an URGENT MEDICAL DEVICE CORRECTION letter dated January 10, 2011, to Operating room managers. The letter informed the customers of the Bipolar cord product life of 50 uses. The letter states that the IFU for the bipolar cord is being updated to include the information regarding the limit of 50 uses and sterlization cycles. The letter recommends that user keep a sterile back up bi-polar cord in a convienent place during endoscopic vein harvesting procedures. The firm provided a tracking sheet in each package to help users track the number of sterlization cycles for the cord. Customers were instructed to review the Medical Device Correction notice, assure that all users were aware of the notice, and confirm receipt of the communicaiton by faxing the attached Customer Response Form to the fax number indicated on the form. For questions regarding this recall call Terumo CVS Customer Service at 1-800-521-2818.

Device

Device Recall VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM
  • Modelo / Serial
    01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 4ZK, 51K, 52K, 53K, 54K, 55K, 6XK, 6ZK, 71K, 72K, 73K, 74K, 75K, 76K, 77K, 78K, 79K, 7XK, 7YK, 7ZK, 81K, 82K, 83K, 84K, 85K, 86K, 87K, 87K, 88K, 89K, 8XK, 8YK, 8ZK, 91K, 95K, 96K, 97K, 99K, 9XK, 9YK and 9ZK.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - United States including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, , NY, MO, MS, MT, NC, NE, NH, NJ, NM, OH, OK, OR, PA, SC, TN, TX, VA, WI, AND WV and the countries of Chile, Hong Kong, Malaysia, United Arab Emirates, Belgium, Japan, Korea, The Phillipines, Singapore, Taiwan, Thailand, Germany, and United Kingdom.
  • Descripción del producto
    Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1, Terumo Cardiovascular System, Ann Arbor, MI. || The Terumo Bipolar cord MCBICORD1 is a flexible, reusable power cable that is indicated for use with the Terumo VirtuoSaph Endoscopic Vein Harvesting System and a compatible generator during saphenous vein harvesting procedures.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA