Model Number UHI-4 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device has not returned to omsc but was returned to olympus service operation repair center (sorc) for evaluation.Sorc checked the subject device and duplicated the reported phenomenon.It was found that led of the front panel of the subject device was not lit properly and displayed abnormal.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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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that it was found the front panel failure of the subject device during the preparation for use.The occurrence date of the event is unknown.There was no patient injury associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The cause of the reported phenomenon could not be identified.However based on the report of olympus service operation repair center (sorc), omsc surmised there was the possibility this phenomenon was attributed to the accidental electrical component failure of the subject device.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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