Events

Rappel de Danis Procedure Pack and Danis Procedure Pack - Basic

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Endotherapeutics Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00242-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00242-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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