Model Number CLV-S40PRO |
Device Problem
Electrical /Electronic Property Problem (1198)
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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 suspect device was returned to olympus and evaluated.The reported problem of front panel display flashing was confirmed.Additional evaluation findings are as follows: narrow band imaging failure; high intensity mode failure.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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Event Description
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A user facility reported to olympus that the narrow band imaging feature did not function and the front panel display was flashing.This report is submitted due to the report of the front panel display flashing.There was no patient injury, associated with the problem, reported to olympus.
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Manufacturer Narrative
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H4 - upon further investigation, the correct manufacture date has been provided.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.It has been over 13 years since the subject device was manufactured.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, it was assumed that the cause of the phenomenon was a malfunction due to turret motor fatigue, causing the front panel to blink.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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