Model Number UCR |
Device Problems
Gas/Air Leak (2946); Pressure Problem (3012)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed due to a loose connection of gas tube.The output pressure was found out of specification due to a bad decompression unit.No other issues were found during the device inspection.If additional information is obtained a supplemental report will be filed.
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Event Description
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A user facility reported a leak causing and endoscopic co2 regulatory unit to lose co2 gas quickly.There was no patient involvement or injuries reported.No additional information has been obtained.
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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.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, although a root cause of the decompressor unit failure could not be conclusively determined, the probable cause is likely due to an accidental failure of the internal decompressor unit.
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Search Alerts/Recalls
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