Events

Recall of Danis Procedure Pack and Danis Procedure Pack - Basic

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Endotherapeutics Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00242-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00242-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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