Model Number TJF-Q180V |
Device Problem
Device Reprocessing Problem (1091)
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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 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 the technical evaluation, it was confirmed that the reprocessing of the device was insufficient.There was no report of patient injury associated with this event including the infection.The user facility did not provide other detailed information.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device in this report was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the information from olympus europa k.G (oekg) there was the possibility that this phenomenon was attributed to the reprocessing handling error of the user because the reported phenomenon is not device malfunction.
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Search Alerts/Recalls
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