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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problems Break (1069); Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to omsc but was returned to olympus (b)(4).(ofr).Ofr sent the device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from the all channels of the device tested positive for unspecified microbes (<1 cfu/endoscope).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.
 
Event Description
Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the device.[first time; (b)(6) 2020] -mesophile flora at 30 (3 cfu/100ml), non pathogenic environmental germs [second time; (b)(6) 2020] -mesophile flora at 30 (1 cfu/100ml), non pathogenic environmental germs [third time; (b)(6) 2020] -mesophile flora at 30 (1 cfu/100ml), non pathogenic environmental germs [fourth time;(b)(6) 2020] -mesophile flora at 30 (13 cfu/100ml), non pathogenic environmental germs 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 device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).The evaluation of the device by (b)(4).Confirmed the following; the instrument channel port was not fixed and was deformed.The image guide bundle was broken.Omsc concluded that the instrument channel port deformation may have been caused by physical stress due to user handling or stress due to the removal of instrument channel parts during (b)(4) inspection.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event that the sample collected from the device tested positive as a result of microbiological testing could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
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Brand Name
FIBERSCOPE "CYF-5", EUROPEAN VERSION
Type of Device
CYSTONEPHROFIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10893255
MDR Text Key227878082
Report Number8010047-2020-09349
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/24/2020
Supplement Dates Manufacturer Received11/20/2020
Supplement Dates FDA Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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