Model Number CYF-5 |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/25/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from suction channel of the subject device tested positive for unspecified microbes (7 cfu).The device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus france.(ofr).Ofr sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from all channels of the device.The testing result cleared the french guideline.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.
|
|
Manufacturer Narrative
|
This supplemental report is being submitted to provide additional information.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 at this time.If additional information becomes available, this report will be supplemented.
|
|
Search Alerts/Recalls
|