Model Number CLV-180 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The suspect device was returned to olympus, however, the evaluation has not been completed at this time.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 unit failed to power on.The problem, as reported to olympus, was identified during preparation for use.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 approved final investigation and the device evaluation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the issue was caused, by a cut fuse component on the alternating current inlet of the power supply.However, the definitive root cause of the cut fuse could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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