Model Number CLV-190 |
Device Problem
Overheating of Device (1437)
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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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As the device was not returned to olympus for evaluation, a root cause for the reported event cannot be determined.If additional information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
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Event Description
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A user facility reported to olympus that an error "e101" occurred and overheating of the device occurred.In addition, it was reported the light source stopped working.There was no patient injury, associated with the problem, reported to olympus.
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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.It has been over 7 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, a root cause could not be identified.Reproducibility of the phenomenon is unknown because the concerned device has not been returned from the facility.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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