Events

Retiro De Equipo (Recall) de ULTRA-SOUND SCOPE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PENTAX CANADA 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
    134836
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-02-10
  • 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
    Hoya corporation/pentax life care division has determined that there is a possibility of cross-contamination for the eg-3870utk ultrasound gastroscope under certain conditions. the potential for cross contamination can occur when there is a clog in the balloon suction channel as there is no method to reliably force fluid specifically through the balloon suction channel when following the present cleaning and high-level disinfection procedure. if the channels are not meticulously checked prior to use the clog might not be detected. there are two known ways that a clog can develop: a. if the balloon is not used and fluid is suctioned from the body cavity using the balloon suction channel a clog can develop. (note that using the balloon suction channel to suction fluid from the body is inefficient due to the small size of the channel.) b. if body cavity fluid is suctioned into the balloon suction channel and a clog occurs the clog may be difficult to detect. the device with an undetected clog might be used in a subsequent patient. in the unlikely event that the scope passes the pre-procedure function check and is then used without the balloon the clog could potentially become dislodged and infused into the next patient resulting in the potential for cross contamination.

Device

ULTRA-SOUND SCOPE
  • Modelo / Serial
    Model Catalog: EG-3870UTK (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    PENTAX ULTRASOUND VIDEO GASTROSCOPE
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    HC