Model Number UCR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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The device in this report has not been 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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The user informed olympus that some patients suffered from barotrauma.The user noticed the complication when they observed some damages on the mucosa that might be consistent with barotrauma during procedures using either ucr serial number (b)(4).The exact number of affected patients is unknown, but at least 5 patients were involved.The user facility is carrying out investigation to see if the root cause of the barotrauma was due to excessive insufflation using co2 at high pressure.Olympus representative has confirmed that the devices were connected to the wall where there are internal co2 pipes, not to a cylinder.Olympus medical systems corp.(omsc) is submitting five medical device reports according to the number of potentially injured patients.This is 2nd of 5 reports.
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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 and device evaluation.The device was returned to olympus for evaluation and the repair center was unable to confirm the customer's complaint.The device flow rate and pressure were within the standard specification.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, it is likely there is no problem with the subject device and that the adverse event occurred because of other equipment (such as the connecting equipment or connection condition).
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Search Alerts/Recalls
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