The bs-4 balloon is not commercially available in the united states.It is similar to the bs-2 balloon which is marketed under k143556.Use of a 10-ml syringe can easily generate a higher pressure than the pressure generated by the balloon controller, and the patient complained of abdominal pain and bleeding was observed immediately after pressurization with the syringe.Therefore, the cause of the health damage is considered to be overpressure due to the use of the syringe.The balloon was not attached properly and was displaced due to the load during the procedure, and the displaced balloon blocked the opening of the channel that supplies air into the balloon, which led to the state where the syringe could increase pressure but not decrease it.If any additional relevant information is provided, a supplemental report will be submitted.
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Double-balloon endoscopy was started on a patient with crohn's disease and strong small intestinal adhesions.The balloon bs-4 at the tip of the scope en-580t ceased to inflate during ileal insertion.The balloon controller pb-20 was removed, and a 10 ml syringe was connected to try to deflate the balloon.The balloon did not deflate, but was able to inflate.Immediately after inflating, the patient complained of severe abdominal pain, and a laceration of the small intestinal mucosa and significant bleeding were observed.Conservative treatment by blood transfusion was performed, but the patient got into shock.Angiography was performed which identified the bleeding point artery, so hemostasis was performed by coiling.
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