Events

Retiro De Equipo (Recall) de ENDOEYE Video Telescope

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus Australia Pty 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
    RC-2015-RN-01141-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01141-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.
  • Acción
    Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.

Device

ENDOEYE Video Telescope
  • Modelo / Serial
    ENDOEYE Video TelescopeENDOEYE 10mm 0 degreesPart #: WA50040AS/N: 622642, 622770, 622774, 622776, 623616, 623617, 623618, 623620, 624087, 624088ENDOEYE 10mm 30 degreesPart #: WA50042AS/N: 622506, 622529, 622530, 622531, 622532, 622533, 622781, 623665, 623667, 623684, 624075, 624094, 624619, 624627ENDOEYE devices repaired with affected spare partPart #: WA50040A or WA500422S/N: 616960, 616963, 617144, 617801, 619863ARTG Number: 121101
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd