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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 Date 09/29/2020
Event Type  Malfunction  
Manufacturer Narrative

The device 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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the device. [first time; (b)(6) 2020] instrument channel: unspecified microbes (7 cfu) [second time; (b)(6) 2020] instrument channel: unspecified microbes (11 cfu) the device had been manually reprocessed using peracetic acid. There was no report of infection associated with this report.

 
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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 Key10761572
MDR Text Key223647495
Report Number8010047-2020-08333
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2020
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? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/02/2015
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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