This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based on the information from olympus korea (okr), omsc surmied causes of each of the reported phenomenon as follows; the water supply function not working could have occured, as the air/water channel got clogged due to a foreign material entered to the channel or insufficient cleaning.The failure of the ultrasound image could have occurred, as the elements of the ultrasonic probe were missing due to damage to the ultrasonic probe by sharp material or excessive force.The gap on the distal end glue could have occurred due to aging deterioration.
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