Events

Retiro De Equipo (Recall) de NEPTUNE ROVER

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

¿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
    43709
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2012-05-14
  • 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
    The stryker neptune waste management system is intended to be used in the operating room pathology surgical centers and doctor's offices to collect and dispose of surgical fluid waste as well as to collect smoke generated from electrocautory or laser devices. stryker instruments was made aware was made aware through informal reports from hospital personnel that a death had occurred and possibly related to use of a neptune rover. the root cause of the problem was confirmed not to be caused by a product malfunction or the result of a non-conformance but rather the event resulted due to a use error.

Device

NEPTUNE ROVER
  • Modelo / Serial
    Model Catalog: 0702-001-000 (Lot serial: ALL); Model Catalog: 0700-007-000 (Lot serial: ALL); Model Catalog: 0700-001-000 (Lot serial: ALL); Model Catalog: 0700-003-000 (Lot serial: ALL)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    IFU FOR NEPTUNE WASTE MANAGEMENT SYSTEM
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC