Model Number UHI-4 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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Event Description
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During an unspecified procedure, the subject device was used.The subject device was used under small cavity mode with 4 pressure and 0.5 flow rate.The device sent out an excessive pressure alarm and smoke evacuation was activated.The intended procedure was completed with another device.There was no patient injury reported.It was reported that similar cases occurred the second time.This is the second of two reports.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, omsc could not identify the cause of the event.The local field service engineer confirmed that the subject device did not have an abnormality.The manufacturing record was reviewed and found no irregularities.Omsc could not identify the root cause of the event.However, based on the local field service engineer report omsc assumes that there was no abnormality in the subject device and the event was attributed to other factors.The instruction manual of the device states the corresponding method when there is an abnormality for the device.
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Search Alerts/Recalls
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