It was reported to boston scientific corporation that two speedband superview super 7 devices were used during a trans-oesophageal ligation of oesophageal varices (lvo) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was rotated in order to deploy an elastic band; however, two elastic bands were able to deploy and happened several times on the same device.The speedband device was removed from the patient, and the second speedband device was used, but the same issue occurred.Reportedly, the deployment failure led to a superficial lesion of the esophageal mucosa which did not require any treatment.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty experienced upon setting up the devices.The patient condition at the conclusion of the procedure was reported to be good.
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