Model Number GIF-H190 |
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 07/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.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 becomes available or if the device is returned at a later time, this report will be supplemented.
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Event Description
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Olympus medical systems corp.(omsc) was informed that in the routine microbiological test by the user facility, the microorganisms were detected as follows, from samples taken from the subject device.The user facility reported that the subject device was reprocessed according to the instruction manual.There was no report of infection associated with this report.Inside of the instrument channel: staphylococcus hominis(2 cfu/channel), dermatococcus species(1 cfu/channel), acinetobacter species(1 cfu/channel).Inside of the air/water channel: dermatococcus species(60 cfu/channel), bacillus species(1 cfu/channel).Inside of the auxiliary water channel: micrococcus species(1 cfu/channel).Inside of the all of the channel: staphylococcus capitis(1 cfu/channel).
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for additional microbiological testing.As a result of additional microbiological testing by a third party laboratory, no microbe was detected from samples taken from the instrument channel, suction channel, air / water channel and auxiliary water channel of the subject device.The exact cause of the reported event could not be conclusively determined at this time.If significant additional information is received, this report will be supplemented.
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Manufacturer Narrative
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This supplemental report is submitting to correct "device product code" and "pma/510(k) number".
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Search Alerts/Recalls
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