The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During the evaluation the syringed was attached to the injection port of the device and was unable to pass fluid all the way through the distal end of the sheath.There was a severe kink on the insertion portion sheath below the handle, which most likely caused the user¿s experience.However, the needle still fully extends from the distal tip and the movement of the slider is normal and smooth.There was no other damage noted with the device.Based on the results of the investigation, it is likely that the following led to the malfunction: that the reported event ¿unable to inject liquid into the target tissue¿ occurred due to 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.·angle of the distal end of the endoscope ·the tube was kinked.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.However, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): ¿¿before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example: posing an infection-control risk, causing tissue irritation, perforation, bleeding, or mucous membrane damage, and may result in more severe equipment damage.·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.¿do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.¿before use, confirm that the needle and the insertion portion are not damaged.If any abnormalities such as significant deformations or excessive bends are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.¿confirm that the needle extends in the endoscopic image are normal.If any abnormalities are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, or mucous membrane damage.¿when inserting the instrument into the endoscope, retract the needle into the tube, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.¿stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.¿do not push the slider abruptly, otherwise the needle will be rapidly extended from the distal end of the tube.This could result in patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the instrument.¿ olympus will continue to monitor the field performance of this device.
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