Events

Retiro De Equipo (Recall) de ESOPHAGUS SET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CSP MEDICAL.

¿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
    19239
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    If the applicator fixation is not securely fixated to the bougie tube or the universal applicator there is a risk of a misplacement of the source so that not the target area but healthy tissue would be irridiated. therefore according to a safety advice in the instructions for use the user has to verify that the applicator fixation is safely fixated to the bougie tube. according to the current procedure this check is carried out after the bougie tube has been introduced. due to the product failure it will not be possible to correct the tightening of the applicator fixation. as a result the patient would have to leave untreated after having been sedated and undergoing the stressful introduction of the bougie tube.

Device

ESOPHAGUS SET
  • Modelo / Serial
    Model Catalog: SET0019 (Lot serial: all batches)
  • Descripción del producto
    ESOPHAGUS SET
  • Manufacturer
    CSP MEDICAL

Manufacturer

CSP MEDICAL
  • Dirección del fabricante
    LONDON
  • Empresa matriz del fabricante (2017)
    CSP Medical
  • Source
    HC