Olympus inspected the device at the service department of olympus (b)(4) (okr) and found that there was a gap of adhesive on the distal end of the device, and stain entered the inside of the light guide lens through the gap.Therefore, the inside of the light guide lens was dirty.There was no report of patient injury associated with this event.
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This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) confirmed from the inspection result of the device by olympus korea co., ltd.That there were multiple scratches and cracks on the light guide lens, and that there was evidence of physical stress.In addition, the inside of the light guide lens was dirty, so there is possibility that water has flooded around the light guide lens.Therefore, omsc determined that there was a gap in the adhesive around the light guide lens.The exact cause of the reported event could not be conclusively determined, however there is possibility that the reported event was caused by the following; physical stress caused by hitting the distal end against an object.Chemical stress caused by chemicals used during reprocessing.Storage environment (stored with water droplets remaining in the air/water channel, and water droplets fell on the light guide lens during storage in the vertical state, etc.).Aged deterioration.The instruction manual provides preventive measures against the reported failure mode.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
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