Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report number 3005099803-2023-04901 for the first exalt model d scope 3005099803-2023-04903 for the second exalt model d scope, 3005099803-2023-04904 for the third exalt model d scope, and 3005099803-2023-04900 for exalt model d controller.It was reported that an exalt model d single use duodenoscope was used during an ercp procedure performed on (b)(6) 2023.During the procedure, visualization was lost and the loading screen appeared.The system was restarted but visualization could not be regained.It was reported that three exalt model d scopes malfunctioned during this procedure.The physician swapped scopes and completed the procedure.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
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