Model Number GIF-1TH190 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not been returned to omsc.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that during routine surveillance culturing test by the facility, the subject device tested positive for stenotrophomonas maltophilia.The customer reported that the subject device was reprocessed according to the instruction for use.The subject device had been disinfected with non-olympus automated endoscope reprocessor (wassenburg) using peracetic acid.There was no report of infection associated with this report.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device evaluation result.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code".
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Search Alerts/Recalls
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