On march 28, 2022, fujifilm healthcare americas corporation became aware of an adverse event involving ed-580xt.It was reported that during an endoscopic retrograde cholangiopancreatography (ercp) sphincterotomy, the subject scope cut right and burned the duodenum.The performing physician stated that leakage from the tip of the scope during the procedure caused cautery of the duodenal wall.No additional intervention was required and the procedure was completed successfully.Two separate incidents were reported involving separate ed-580xt scopes.This report addresses the second scope with serial # (b)(4).There was no death associated with the event, and the burn was determined to be minor.As such, this report is being submitted in an abundance of caution.
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