Model Number CLV-190 |
Device Problem
Installation-Related Problem (2965)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
malfunction
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Event Description
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A user facility reported to olympus that they were unable to reinstall the main lamp heatsink assembly.There was no patient involvement, associated with the event, reported to olympus.
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Manufacturer Narrative
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The reporter resolved the problem and the device was not returned to olympus for evaluation.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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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the legal manufacturer's investigation, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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