During the inspection of the returned device, the device failed the leak test and there were worn angle wires and the up/down knob could not be locked securely (due to the forceps elevator being deformed).Scratches were found on the connecting tube, universal cord, universal cord protector on the side connector (the side connector side on the control body), the side connector on the control body, side cover on the control body, distal end, light guide cover glass, switch box button #1, forceps channel, grip, control unit and the acoustic lens.The side cylinder, bending section cover and light guide lens were found to be dirty.In addition, the adhesive on the bending section cover was detached, the light guide bundle has breakage and the water tightness was lost.The device failed the water removal inspection.The nozzle/forceps elevator was noted to have debris.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation.
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The customer reported to olympus, the knob on the evis exera ii gastrointestinal videoscope was leaking.The device also had low angulation and was experiencing angulation play.During the inspection of the returned device, the nozzle/forceps elevator was obstructed with debris, which was attributed to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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