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 was confirmed and the cause assigned to a filter turret and mesh turret malfunction (sticking).In addition, the evaluation found a burnt ac power inlet and the high intensity mode was not functioning.The investigation is ongoing and the 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 front panel was blinking.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 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, and information from the repair department, the burnt inlet can be confirmed.It was not possible to identify the cause of the phenomenon.Other incoming inspection findings: the repair department also confirmed that the front panel was blinking and obtained information that it was due to a malfunction of the filter turret and mesh turret.Also, the output connector¿s high brightness mode cannot be entered due to a failure of the high brightness detector.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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