Olympus discovered the MAJ-1444 may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines. Specifically, when the MAJ-1444 is put into the washing case with other accessories of the ultrasonic endoscope, such as suction valve MAJ-1443, which may collide against each other causing damage. If the MAJ-1444 loses one-way valve functionality, body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure. There is no check that can be performed by users which evaluates one-way valve functionality. Therefore, a risk to patient health exists: 1) if the body fluid remains in the channel of the ultrasonic endoscopes following reprocessing, and 2) if the contaminated ultrasonic endoscope is used for the next patient without realizing the body fluid during the inspection, then a contaminated ultrasonic endoscope channel can cause transmission of infection. Recall Start Date: July 13, 2023
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