Model Number UHI-4 |
Device Problems
Contamination (1120); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was evaluated, and the reported issue was confirmed.The tubing/piping inside the unit had large amounts of black residue and failed the flow rate test.There was a loose screw from the first regulator unit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The distributor reported on behalf of the customer, the high flow insufflation unit had internal liquid in the hoses.The issue was found during preventative maintenance prior to a therapeutic procedure.The intended procedure was not completed as it was not scheduled.A back-up device was not available.No patient harm reported.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation and to correct h6 medical device problem code.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the definitive root causes of the foreign material could not be determined.The foreign material may have came from the internal components or due to an external cause.It is possible that an external factor was involved, such as wrong handling.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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