This device referenced in this report has not been returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus regional repair center in europe (rrc).Rrc removed the bending rubber of the subject device and confirmed a crack in the bending tube.From our causal investigation result, it was confirmed that under the condition where the distal end of the scope comes in contact with an inner wall of a kidney, if the scope is repeatedly further pushed, the bending tube breakage occurs.Therefore, the bending tube breakage in this report is considered to have occurred in the above mechanism.The instruction manual contains several statements in an effort to prevent bending section damage.¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ ¿do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.¿.
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