Since the subject device was discarded, it was not returned to olympus medical systems corp.(omsc) for evaluation.The lot no.Was unknown.Therefore, as the result of checking the manufacturing record of three months in the past from (b)(6) 2016 (delivery date), there was nothing abnormal detected.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it is known that the needle could not be retracted into the sheath due to buckling the sheath.The buckling of the sheath might be caused by the excessive stress applied to the sheath while inserting forcibly the subject device into the endoscope or manipulating excessive angulation of the endoscope.The instruction manual of the subject device warns; when inserting the instrument into the endoscope, retract the needle into the sheath, 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 force the instrument if resistance to insertion is encountered.Reduce the angulation of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.
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