Model Number UCR |
Device Problem
Backflow (1064)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report was not returned to 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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Olympus medical systems corp.(omsc) was informed by the user facility that it was found the gas flow indicator illuminates red during insufflation.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.Olympus service operation repair center (sorc) checked the subject device and found that the reported phenomenon was duplicated.Additionally, it was found that there was a trace of liquid ingress into the inside tube of the subject device.
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Manufacturer Narrative
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This is a supplemental report to provide additional information.Since the subject device was not returned to olympus medical systems corp.(omsc), it could not be investigated.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the information from sorc, there was the possibility that this phenomenon was attributed to the backflow of liquid.If additional information becomes available, this report will be supplemented.
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Manufacturer Narrative
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This supplemental report is to inform that upon further review, per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Initially, we determined that the event was mdr reportable due to a backflow of liquid from the water container into the unit co2 regulator (ucr), in which case we determined that it was a potential adverse event because of the risk for infection.Upon further investigation, it was found that liquid does not flow back into the ucr from the water container unless multiple situations occur simultaneously.There are no reports of situations occurring for this complaint.In addition, a component analysis was performed on the water droplet traces in the tube of the ucr at a similar complaint.The results of this component analysis detected silica and others that appeared to be derived from tap water, but no component that appeared to be body fluids were detected.
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Search Alerts/Recalls
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