Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
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It was reported to boston scientific corporation that a speedband superview super 7 device was used in the esophagus during an esophagogastroduodenoscopy (egd) with banding procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the first band successfully deployed, but the next band would not fire even after an audible click.There was no difficulty experienced upon setting up the device.The procedure was completed with another speedband superview super 7 device.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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