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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 CYSTO-NEPHRO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION CYSTO-NEPHRO FIBERSCOPE 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 02/14/2018
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned to olympus medical systems corp. (omsc). 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 was informed that the subject device tested positive for staphylococcus warneri(3cfu/100ml) during routine surveillance culturing test by the facility. The portion of the subject device, where the microbes were detected, was not reported. The facility had reprocessed the subject device with anioxy-twin. There was no report of patient infection associated with this report.

 
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Brand NameFIBERSCOPE "CYF-5", EUROPEAN VERSION
Type of DeviceCYSTO-NEPHRO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key7347974
MDR Text Key103277266
Report Number8010047-2018-00466
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK032092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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