Model Number CYF-VHA |
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 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.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 microbiological testing by the user facility, the subject device tested (b)(6) for unspecified microbes.The user facility did not provide other detailed information such as the number and the type of microbes.Other detailed information such as the reprocessing method was not provided.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.Olympus medical systems corp.(omsc) investigated the subject device and found the following.-the light guide lens of the distal end had scratches.-the adhere of the bending section rubber had a chip.-the electrical contact of the video connector had scratches.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
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Search Alerts/Recalls
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