Note: this report pertains to a spyscope ds ii access and delivery catheter and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii access and delivery catheter was used with a spyglass ds controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct (cbd) on (b)(6) 2020.According to the complainant, during the procedure, while they were into the common bile duct, the image of the spyscope ds ii disappeared immediately for several times while they were into the procedure.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
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