This supplemental report is being submitted to provide additional information.In addition to the phenomenon described in the initial report, there was the stain inside the light guide lens.The subject device in this report was not 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 upon the information from olympus india there was the possibility that the reported phenomenon was attributed to the stain invasion into the device from the peeled adhesive around the light guide lens.The exact cause of the peeling of adhesive could not be conclusively determined, there was the possibility that the peeling was attributed to the external stress such as hitting the distal end, or the chemical stress of reprocessing, or storage environment.
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