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 two speedband superview super 7 devices were used in the esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device failed to deploy any elastic bands.The same issue occurred with the second speedband superview super 7 device.There was no difficulty in setting up the device.The procedure was completed with another speedband superview 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.
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