It was reported to boston scientific corporation that two speed band super view super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(4) 2019.According to the complainant, during the procedure, the device failed to deploy any elastic bands.The same issue occurred with the second speed band super view super 7 device.There was no difficulty in setting up the device.The procedure was completed with another speed band super view super 7.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.
|