The subject device was returned to olympus medical systems corp.(omsc) for evaluation.When the slider was pushed, the needle would not extend from the outer tube.When the slider was pushed, it was unable to inject a liquid.However, when the slider was pulled, it was able to inject a liquid.The tube was kinked at about 130 mm and 1170mm from the distal end.The needle tube had compressive buckling.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the kinks of the tube and the compressive bucking on the needle tube.The compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The kink of the tube.Angle of the distal end of the endoscope the kinks could have resulted from physical bending load applied to the outer tube during insertion into the endoscope, unpacking of the sterile bag, or pre-use inspection.The above device handling has warned in the instruction manual.
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