Olympus could not investigate them because the user disposed of the subject devices.Since the manufacture record of the subject devices were unknown, the manufacture record that dated back the past one year from the delivery date to the user was reviewed without apparent irregularity associated with the subject phenomenon.Judging from the past similar cases, there are possibilities that the cause of this phenomenon is kinked tube.It is considered that upon inserting this subject device into a scope, the tube was bent and kinked.This report is being submitted as a medical device report in an abundance of caution.
|