Model Number CLV-190 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The light source referenced in this report was not returned to olympus for evaluation.However, olympus technical assistance center representative troubleshooted the reported issue with the customer over the phone.Based on the troubleshooting performed the customer reported that the communication error was attributed to the colonoscope and no problem was found with the light source.The colonoscope was returned for service.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported to olympus that, the evis exera iii xenon light source had a communication error code b30 when connected to 190 scopes.There was no harm or user injury reported due to the event.
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Manufacturer Narrative
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The light source referenced in this report was not returned to olympus for evaluation.However, olympus technical assistance center representative troubleshooted the reported issue with the customer over the phone.Based on the troubleshooting performed the customer reported that the communication error was attributed to the colonoscope and no problem was found with the light source.The colonoscope was returned for service.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported to olympus that, the evis exera iii xenon light source had a communication error code b30 when connected to 190 scopes.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 approved final investigation and the initial reporter's title in sections e2 and e3.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, there was no issue associated with the light source.It was unclear if the phenomenon would be duplicated because the subject device was not returned from the facility.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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