Events

Retiro De Equipo (Recall) de INNOVA E4 WASHER - DISINFECTOR

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

¿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
    16777
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-16
  • 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
    A hospital contacted scican on march 10 2016 to report difficulties with one of their e4-wd washer-disinfectors. the hospital's biomedical technician reported that he identified the upper water flap of one channel being stuck in the closed position. according to the hospital's biomedical technician a screw securing the water flap was suspected to be responsible for this issue. that specific screw was apparently loose and deflected the stainless steel insert spacer from its normal position causing it to miss the water flap which consequently remained closed. as the water flap was stuck in the closed position it did not allow the proper circulation of water and chemicals in the upper scope. the scopes located in that specific location were not reprocessed correctly. the biomedical technician has confirmed that this water flap was opening correctly until march 9th 2016.

Device

INNOVA E4 WASHER - DISINFECTOR
  • Modelo / Serial
    Model Catalog: E4-WD (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    INNOVA E4 WASHER-DISINFECTOR
  • Manufacturer
    SCICAN LTD.

Manufacturer

SCICAN LTD.
  • Dirección del fabricante
    TORONTO
  • Empresa matriz del fabricante (2017)
    Scican Ltd
  • Source
    HC