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 07/28/2021 |
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).(b)(4) checked the subject device and found that the reported phenomenon was caused by the failure of the power unit.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during routine inspection by technician, 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.Based upon the information from omsi, omsc surmised that the reported phenomenon was attributed to the aging deterioration failure of the power unit due to the long-term user because over ten years had passed from the subject device had been manufactured.
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Search Alerts/Recalls
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