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) 2020.According to the complainant, during the procedure, multiple bands shot off at once and did not fire together.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.
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