Events

Retiro De Equipo (Recall) de Danis Procedure Pack and Danis Procedure Pack - Basic

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Endotherapeutics 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-2017-RN-00242-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-08
  • 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-2017-RN-00242-1
  • 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 manufacturer ella-cs has identified an unintended positioning of the safety valve of the fixation- gastric balloon of the delivery system in the danis procedure pack. this issue will cause the surgeon to not be able to insufflate the fixation – gastric balloon and hence, be unable to correctly place the delivery system. as such, the surgeon will to have to stop the acute oesophageal variceal bleeding using another danis stent, or other methods, which may prolong the procedure and bleeding. this extension of the procedure may cause deterioration of the patient’s condition and health. at this stage, the manufacturer is not aware of any reported injury connected with this issue.
  • Acción
    Endotherapeutics is advising surgeons to check the position of the safety valve. If the safety valve does not cover the opening designed for spontaneous deflation of the fixation – gastric balloon, to return it to the appropriate position to allow performance of the stent implantation with fixation of the delivery system in the cardia. Surgeons are further advised that if the safety valve does not cover the opening for spontaneous deflation of the fixation – gastric balloon and it is not returned to the appropriate position, the Danis stent can be introduced by conventional techniques for the implantation of oesophageal stents.

Device

Danis Procedure Pack and Danis Procedure Pack - Basic
  • Modelo / Serial
    Danis Procedure Pack and Danis Procedure Pack - BasicProduct Reference Numbers: 019-08S-25-135 and 019-08S-25-135-BLot Numbers: P14080073-01, P15020247-01, P15030171-01, P15110018-01, P15100210-01 and P17010044-01 ARTG Number: 95573
  • Manufacturer
    Endotherapeutics Pty Ltd

Manufacturer

Endotherapeutics Pty Ltd