Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f1001 is being used to capture the reportable issue of absence of treatment.Hospital name: (b)(6).
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It was reported to boston scientific corporation that the lithovue flexscope was used during procedure performed on (b)(6) 2023.During the procedure, the scope was plugged in, and no image appeared on the monitor.For testing purposes, a demo scope was also used to check the image, and no image appeared.The procedure was cancelled due to this event.There were no patient complications as a result of this event.
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