Danis Procedure Pack and Danis Procedure Pack - Basic 의 리콜

Recall

RC-2017-RN-00242-1

Class II

2017-03-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00242-1

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.

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.