Model Number CLV-190 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has been returned to olympus for evaluation and the reported issue was not confirmed.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, during an unknown procedure, the iris, and the auto focus of the evis exera iii xenon light source were not working.Subsequently, the intended procedure was completed with the same device.There was no harm or user injury reported due to the event.
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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.Correction to b5 for information inadvertently left out.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 the device malfunction was not 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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Event Description
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The device used during the procedure was inspected prior to use.Error messages were not observed and the procedure was not prolonged as a result of the reported problem.Medical intervention was not performed and no other devices were connected to the subject device when the failure occurred.
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Search Alerts/Recalls
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