The complainant was unable to report the serial number; therefore the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
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Note: this report pertains to a spyscope ds ii and a spyglass ds controller that were used during the same procedure.It was reported to boston scientific corporation that a spyscope ds ii was used with a spyglass ds controller during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2020.According to the complainant, during the procedure, the image of the spyscope ds ii was intermittently cutting out and getting fuzzy, then the grey screen with spyglass image appeared.Reportedly, the image was lost approximately 30 minutes into the procedure.The procedure was not completed due to this event.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 stable.
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