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 that there was a brown part around the light guide lens and there was evidence of flooding, from the inspection result of the device by olympus korea co., ltd (okr).In addition, the light guide lens had multiple scratches and cracks, and there was evidence that the light guide lens was physically stressed.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.Chemical stress.Storage environment (direct sunlight, high temperature, high humidity, environment exposed to x-rays and ultraviolet rays, etc.).Aging.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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