Olympus medical systems corp.(omsc) was informed that during an unspecified procedure, the user could not pass a basket type forceps or a laser probe through the instrument channel of the subject device.Therefore, the user replaced the subject device with another device and completed the procedure.There was no patient injury associated with this event reported.
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This supplemental report is being submitted as this device referenced in this report has been returned to olympus (b)(4) for evaluation.During the evaluation, it was confirmed that a part of the bending rubber of the subject device was cut and missing.It was also confirmed that the bending tube was separated and a cable support fixed on the bending tube was deformed.It might be a possible cause for the cut of the bending rubber that the subject device was inserted / withdrawn while calculus was contacted with the bending rubber.From our causal investigation result, it was confirmed that under the condition where the distal end of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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