The subject device was returned to omsc for evaluation.Based upon the evaluation of the subject device by omsc, it was confirmed that there were foreign substances around the objective lens, at the opening of instrument channel of distal side, both sides of glue at the bending cover, at the root of the angulation lever, at the venting connector and at the instrument channel port.It was also confirmed that a point of insertion tube was collapsed.Furthermore, the pipe sleeve of light guide was damaged and water leakage was confirmed.The insertion tube was buckled and the leakage was observed.Base on the findings, inappropriate reprocessing by the user could not be ruled out as a contributory factor of the event.The manufacturing history was reviewed, with no irregularities related to this problem noted.If additional information becomes available at a later time, this report will be supplemented.Please cross reference the associated complaint files: mfr report#: 8010047-2015-00345 and 8010047-2015-00346.
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