Events

Retiro De Equipo (Recall) de Device Recall CRYOCARE SURGICAL 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 Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc..

¿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
    54004
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1400-2010
  • Fecha de inicio del evento
    2008-12-05
  • Fecha de publicación del evento
    2010-04-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87124
  • 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
    Cryosurgical unit and accessories. - Product Code GEH
  • Causa
    Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. an autopsy attributed the cause of death to an air embolism. the safety notice for the cryoprobes was issued to refocus attention on the indications and safety review included with the physician training materials and to reinforce additional safety information.
  • Acción
    The recall was initiated with Endocare sending a notification letter to identified customers on December 5, 2008 and offering an optional replacement unit. The initial correspondence was sent out via an e-mail if the correspondence was returned undeliverable or an e-mail address was not available it was then sent Federal Express to those recipients. The notification letter explained the reason for recall and requested providers refocus their attention on the Indications & Safety Review information contained in the Endocare's Physician Training Materials. Physicians were instructed to contact the firm at 1-949-450-5412 to discuss any questions they may have about the information in the notification letter.

Device

Device Recall CRYOCARE SURGICAL SYSTEM
  • Modelo / Serial
    Lot Numbers 08-0522.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    V-Probe, Endocare Cryo V Probe model # Cryo 206V. || The product is used in a minimally invasive, percutaneous approach || to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue.
  • Manufacturer
    Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.

Manufacturer

Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc.
  • Dirección del fabricante
    Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc., 201 Technology Dr, Irvine CA 92618-2400
  • Source
    USFDA