Model Number UHI-4 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.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 the subject device could not be turned on during an unspecified timing.The user facility completed the intended procedure with the subject device.The service department of olympus trading (b)(4) limited checked the subject device and found the followings.The main circuit board had failure.The subject device turned black out when it was turned on.There was no patient injury associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found that the reported phenomenon was resolved.Omsc reviewed the manufacturing history (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 olympus china, there was the possibility that the reported phenomenon was attributed to the failure of the main board.
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Search Alerts/Recalls
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