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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

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION Back to Search Results
Model Number WA20810A
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2018
Event Type  Malfunction  
Manufacturer Narrative

The subject device has not been returned to omsc but was returned to (b)(4). (b)(4) sent this device to a third party laboratory for additional microbiological testing. The additional microbiological testing indicated no microbial growth for the all channels of this device. Therefore, it cleared the french guideline. 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.

 
Event Description

Olympus medical systems corp. (omsc) was informed that as a result of routine microbiological testing by the user facility, the subject device tested positive for enterobacter cloaceae(3 cfu/100ml). This device had been reprocessed manually with peracetic acid. The user facility reported that this device was reprocessed according to the instruction manual. There was no report of patient infection associated with this report.

 
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Brand NameFIBERSCOPE "CYF-5", EUROPEAN VERSION
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 Key7295558
MDR Text Key101351176
Report Number8010047-2018-00318
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberWA20810A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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