Model Number CLV-S40PRO |
Device Problem
Erratic or Intermittent Display (1182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The evaluation confirmed the reported issue of blinking front panel.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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The customer reported to olympus during an unknown procedure, the front panel started blinking.The user continued use and completed the procedure.There was no patient 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.It has been over 13 years since the subject device was manufactured.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 legal manufacturer's investigation, a root cause could not be identified.Although the reproduction test was conducted using the facility product clv-s40pro, the phenomenon could not be confirmed.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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