The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of leakage from bending section cover was confirmed.Due to a cut on bending section cover; water tightness was lost.The allegation of leakage from distal end was confirmed.Due to damage on channel tube; water tightness was lost.In addition to evaluation in b5; due to damage on forceps pipe; water tightness was lost.The bending section cover had a cut.The connecting tube had discoloration; due to wear of angle wire.Bending angle in down direction did not meet the standard value, due to wear of angle wire; the play of up/down knob was out of the standard value, due to wear of angle wire; the play of right/left knob was out of the standard value, due to wear of forceps wire; the forceps raising angle did not meet the standard value.Grip had a scratch, the universal cord had discoloration, the scope cover had a scratch, the right/left knob was dirty, the up/down knob was dirty, forceps control lever was dirty, the scope connector had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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An olympus field service engineer reported on behalf of a customer, the evis exera ii ultrasound gastrovidoscope experienced an air/water leakage from bending section cover and suction channel.The event was found during maintenance.There was no report of patient harm.During incoming inspection, the foreign elevator had foreign material; due to insufficient cleaning.The unknown foreign material was yellowish-brown in color.Also, the inside of the light guide lens was dirty and distal end had a crack.This medwatch is being submitted to capture the reportable malfunctions found during evaluation.
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