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Model Number CLV-190 |
Device Problems
Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer originally returned his olympus evis exera iii xenon light source due to an inadequate air flow issue noted during procedure preparation.According to the initial reporter, the intended diagnostic procedure was completed, without patient harm, using another device.During the device evaluation, it was discovered that the unit had experienced fluid intrusion into the tubing.This report is being submitted to capture the fluid intrusion found during the device evaluation.
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Manufacturer Narrative
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The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.As noted in b5, there was a foreign liquid discovered in the tubing that caused the restricted air flow issue.Additionally, there were scratches found on the lamp door and top cover.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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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.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, the definitive root cause of the foreign material could not be determined.It is possible that the foreign matter entered due to a socket failure.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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