Events

Retiro De Equipo (Recall) de Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConMed Linvatec 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-2016-RN-01601-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-12-13
  • 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-2016-RN-01601-1
  • 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 reason for this recall is that the device could cause a patient overpressure situation without any visual or auditory indication or warning from the device. if specific conditions occur, the affected unit could create an overpressure which is transient and reversible, requiring intervention from medical staff. if the device were to fail, the surgical attendants, anaesthetist or doctor would see an over -distension of the pneumoperitoneum or difficulty in patient breathing. the manufacturer has received one adverse event report overseas where the device caused an overpressure situation.
  • Acción
    Conmed is advising users to immediately check their facility for the affected unit(s) and to contact Conmed, who will in turn organise collection of the affected unit and return of the corrected unit. If necessary, Conmed will provide a loaner device whilst the product correction is undertaken.

Device

Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an...

Manufacturer

ConMed Linvatec Australia Pty Ltd