The subject device was returned to omsc for evaluation.The exact cause has been under investigation, therefore the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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The subject device was returned to olympus medical systems corp.(omsc) for the evaluation.Omsc checked and confirmed followings; visual inspection result; it was not found the green or gray liquid from/around the subject device which the user has found.It was found the holes on the bending rubber of the subject device.It was found the scratch on the adhesive part of the bending rubber section of the subject device.Air leak inspection.It was found the leak from the bending rubber of the subject device.Function and image inspection.It was found no abnormality for the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However based on the user report and the evaluation, omsc surmised there was the possibility this phenomenon was attributed to the holes on the bending rubber section which made the liquid come into the subject device because the holes were found at the omsc inspection.Since there were no reports that the holes had found at reprocessing before/after procedure, the holes might have occurred at the handling.Also since it was found the scratch on the adhesive part of the bending rubber section, the bending rubber might had been applied some external force.If additional information becomes available, this report will be supplemented.
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