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.
|
This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) confirmed that there was evidence of flooding around the light guide lens from the inspection of the device by olympus korea co., ltd (okr).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.-chemical stress.-storage environment (direct sunlight, high temperature, high humidity, environment exposed to x-rays and ultraviolet rays, etc.).-aging.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.
|