Model Number TJF-Q180V |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to 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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Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the device.Unspecified channel: staphylococcus epidermidis the device had been manually reprocessed using detergent instrunet.Then the device had been reprocessed an automated endoscope reprocessor model wassenburg 440.After this event, the user reported to olympus representative that the result of additional microbiological testing by the user facility showed that the device was negative.Reportedly, the device is working now normally.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 additional information.The subject device has not been returned to omsc.Olympus received additional information from the user facility that the device tested positive for staphylococcus epidermidis in the routine culture test.The device continues to be used normally, as the user facility received the negative result in the re-culturing test.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.
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Search Alerts/Recalls
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