This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The insertion portion and the handle section were not deformed or buckled.As a confimation result of the lock mechanism and the smoothness of the needle adjuster lever, there was no abnormality.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the needle adjuster lever could not be fixed since the needle adjuster was fixed to the convex position instead of the groove at the handle.The above device handling has warned in the instruction manual as follows.*before pushing the needle slider, confirm that the needle adjuster is fixed firmly.Be sure to firmly fix the needle adjuster.Otherwise, it could cause excess extension of the needle from the distal end of the sheath and perforation, bleeding, or mucous membrane damage may result.*if you feel excessive resistance while operating the needle adjuster lever, release the needle adjuster lever once and fix it again.Otherwise, it could damage the needle adjuster lever and patient injury, such as perforation, bleeding, or mucous membrane damage could result.
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