Model Number CLV-S40PRO |
Device Problem
Break (1069)
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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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Olympus inspected the device at olympus service operation repair center (sorc) and found that the ac power inlet was burnt.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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The user returned the device to sorc for repair because the front panel flashed on startup.The device was evaluated at sorc.As a result of the evaluation, the following was confirmed.-the event reported by the user was not reproduced.-the filter turret and mesh turret were stuck and malfunctioned.-the light guide connector was worn.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The exact cause of the reported event could not be conclusively determined because no information was provided about the cause of the reported event from the evaluation result of the device.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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