Model Number GIF-2TH180 |
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 11/23/2017 |
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 as a result of microbiological testing by the user facility, the air/water channel of the subject device tested positive for micrococcus sp (1cfu/channel) and the rubber ring of the subject device tested positive for bacillus sp (1cfu/25cm2).The detail of the ¿rubber ring¿ was not informed from the facility.The test result cleared the french guideline.The subject device had been disinfected using an olympus automated endoscope reprocessor model etd3 (not available in the u.S.) with 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 additional information.The ¿rubber ring¿ in which bacillus sp (1 cfu/25cm2) was detected means the glue of the bending rubber.
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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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