Model Number UHI-4 |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant 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 insufflation function didn't work.Other detailed information was not provided.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 additional information.Olympus medical systems corp.(omsc) could not investigate the device, because the device was not returned to omsc.Omsc reviewed the manufacturing history (dhr) of the device and confirmed no irregularity.Olympus local service engineer report that the device is working normal.Omsc surmised that the reported phenomenon was occurred due to the main circuit board of the device did not work properly temporarily by some cause.The instruction manual of the device states the corresponding method in case of an abnormality.
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Search Alerts/Recalls
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