Events

Retiro De Equipo (Recall) de Device Recall Integra CEM Nosecones

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 Integra LifeSciences 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
    64318
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0920-2013
  • Fecha de inicio del evento
    2013-01-07
  • Fecha de publicación del evento
    2013-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115811
  • 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
    Device, neurosurgical fragmentation and aspiration - Product Code LBK
  • Causa
    There is a potential for erosion of the cusa excel tip used with the nosecone. specifically, the potential for tip erosion occurs when using a cusa cem nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. this erosion can potentially lead to tip breakage. there were no reports of a patient injury associated with these complaints.
  • Acción
    Integra sent a Urgent Medical Device Recall Field Safety Notices dated January 7, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed of the nature of the issue and how if affects CUSA top erosion/breakage; advises customers and provided a copy of the CEM Nosecone IFU additional Warning; and requess customers to complete and return the Acknowledgement Return Form. Please feel free to contact our service hotline at ( 888 ) 772-7378.

Device

Device Recall Integra CEM Nosecones
  • Modelo / Serial
    CEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500,  1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710.  CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1123051, 1123052, 1123508, 1123511 and 1124053.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.
  • Descripción del producto
    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. || The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.