It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle was turned normally, but no bands were able to deploy.The procedure was completed with another speedband superview super 7 device.It was noted that there was no difficulty experienced upon setting up the device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
|