Model Number GIF-H180 |
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 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device in this report has not been returned to 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 microbes 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.Fir1st time: - pseudomonas aeruginosa ( >100 cfu).Second time: - pseudomonas aeruginosa ( >100 cfu).Third time: - bacillus spp.Mesophiles ( 3 cfu).- coagulase-negative staphylococci ( 6 cfu).
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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 this device to a third party laboratory for additional microbiological testing.As a result of additional microbiological testing by a third party laboratory, the following results were obtained.Therefore, it cleared the french guideline.Instrument channel: 3 cfu/100ml (coagulase - negative staphylococci).Suction channel: no microbe.Air/water channel: no microbe.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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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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