It was reported to boston scientific corporation that two speedband superview super 7 devices were used during an esophageal varicose ligation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the bands were attempted to be deployed, but the bands would not release.Reportedly, the device was removed from the patient and it was noted that the suture was not installed on the ligator cap.A second speedband device was used; however, the device fail to deploy elastic bands as there was no suture attached on the ligator head.The procedure was completed with another speedband superview super 7 device.Additionally, there was no difficulty setting up the devices.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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