This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The sheath was broken at 460 mm from the distal end.The manufacturing record was reviewed and found no irregularities.This type of the event is most likely related to the operator's technique.Based on the past similar cases, it was known that the friction between the outer tube and the needle tube increased due to the bending of the tube, and then the needle could not be retracted into the outer tube.Also, the bending of the outer tube occurred due to applying excessive force to the outer tube when the device was inserted into the endoscope, when it was taken out from the sterile bag, or when pre-use inspection was performed.The instruction manual of the device has already warned as follows; insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.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.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.
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