Model Number CLV-190 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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An olympus demo evis exera iii xenon light source was being evaluated, and during the evaluation it was discovered that the power supply switch was failing.There was no patient involvement during this event.
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Manufacturer Narrative
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This complaint is for a demo device that was being evaluated.During the evaluation, it was discovered that the main xenon lamp was about to expire.The device also had a faulty power supply unit, causing the spare lamp to come on intermittently.The output socket was worn out due to general wear and tear.The high intensity mode was only working intermittently due to a faulty main pc board.Minor dents and scratches were also noted on the unit.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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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 h8.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the power supply failure cannot be specified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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