This device referenced in this report has been returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation, a split in the bending rubber and a rupture of the bending tube of the subject device were confirmed.As the bending tube was ruptured diagonally, the stress to the bending tube might be from right or left side of the bending tube.The manufacturing record of the subject device was reviewed with no irregularity.It might be a possible cause for the split of the bending rubber that the subject device was inserted / withdrawn while calculus was contacted with the bending rubber.From our causal investigation result, it was confirmed that under the condition where the distal end of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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