Model Number CLV-190 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and inspected by olympus.The customer report could not be confirmed, the unit passed a full inspection.The investigation is ongoing, and a 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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Event Description
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The customer reported to olympus intermittent lighting issue on their evis exera iii xenon light source during an unspecified procedure.Additionally, the customer stated the bulb needed to be replaced and the picture was dim when backed away from the body cavity walls during procedures.They replaced the bulb and performed functional testing with no issues.However, they did note high mode was nonfunctional and called to troubleshoot with the service center.Additional troubleshooting was performed; the light source and central processing unit were not working so they called olympus service center for repair.There were no reports of patient death, harm or injuries related to this event.
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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.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 investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue 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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