Model Number CV-180 |
Device Problems
Electrical /Electronic Property Problem (1198); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was not returned to omsc for evaluation but was returned to olympus medical systems (b)(4).Olympus medical systems (b)(4) checked the subject device and found that the reported phenomenon was duplicated due to the failure of the power unit.Omsi surmised that the reported phenomenon was caused by the high voltage being applied to the subject device because there was burnt marks inside the power supply unit.The exact cause of the reported event could not be conclusively determined at this time.
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Event Description
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Olympus medical systems corp.(omsc) was informed from the user that during preparation for use, it was found that the subject device could not be turned on.There was no report of patient injury associated with the event.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus medical systems india (omsi).Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from omsi, there was the possibility that this phenomenon was attributed to the failure of the power unit due to the aging deterioration because about fourteen years had passed from the subject device had been manufactured.
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Search Alerts/Recalls
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