Model Number CLV-190 |
Device Problems
Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.While troubleshooting with olympus technical assistance center, the customer confirmed the scope connectors were wiped with alcohol.To narrow down the source of the malfunction, they were advised to swap the light source/data cables out with alternatives to see if it is a cable issue, or swapping out the scope.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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The customer reported to olympus that the evis exera iii xenon light source was intermittently producing scope communication errors b30 and e216.There were no reports of patient harm.
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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 root cause of the b30 error code was unable to be identified as the subject device was not returned.Olympus will continue to monitor field performance for this device.
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Manufacturer Narrative
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This report is being supplemented to provide additional information, provided by the customer.
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Event Description
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The event occurred in may.On several different dates with different scopes.The issue was found in the middle of a procedure, during a diagnostic colonoscopy.It was completed with the device, after the image returned.There was no delay reported.Related patient identifiers: (b)(6).For the additional occurrences of this issue.
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Search Alerts/Recalls
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