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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 Problem Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device has not been returned to omsc but was returned to (b)(4). (b)(4) 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 the all channels of the subject device. 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, following microbes were detected from the sample collected from the subject device. Air/water channel and suction channel: micrococcus lentus (1 cfu/100ml) 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. 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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Brand NameFIBERSCOPE "CYF-5", EUROPEAN VERSION
Type of DeviceCYSTONEPHROFIBERSCOPE
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 Key10624228
MDR Text Key221839967
Report Number8010047-2020-07177
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/03/2020
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? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/19/2012
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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