Problem code 1158 relates to the reportable issue of bands failed to deploy.Problem code 1484 relates to the reportable issue of bands deployed prematurely.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) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the first two bands successfully deployed.Another attempt was made; however, two bands deployed at once and the remaining bands failed to deploy.The procedure was completed with another speedband superview super 7 device.Additionally, the physician noted that there was no difficulty when 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.
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