Model Number CV-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 12/27/2021 |
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 failed power supply.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 olympus, model cv-180, evis exera ii video system center, failed to power on.There was no patient injury, associated with the problem, reported to olympus.
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Event Description
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The problem, as reported to olympus, was identified during preparation for use.The intended procedure was a diagnostic endoscopic ultrasound and was cancelled.A delay in procedure occurred due to the problem; there was no adverse health effect the patient that occurred attributed to the delay.
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Manufacturer Narrative
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This supplemental report is submitted to provide additional event related information.
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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.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 14 years, since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the faulty power supply unit 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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