Model Number UHI-4 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device in this report 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 becomes available, this report will be supplemented.
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Event Description
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During appendectomy, the carbon dioxide pressure in the patient's abdomen was insufficient when the device inflated the affected area of the patient.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The device was not returned to olympus for evaluation and the cause of the reported issue could not be determined.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.
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Search Alerts/Recalls
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