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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE Back to Search Results
Model Number CYF-5
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject device has not been returned to omsc but was returned to olympus (b)(4). (b)(4) sent the subject device to a third party laboratory for microbiological testing. As a result of additional microbiological testing by a third party laboratory, no microbe was detected from samples taken from the instrument channel of the subject device. The result of the additional microbiological testing by a third party laboratory satisfied the (b)(4) guideline. The exact cause of the reported event could not be conclusively determined at this time.

 
Event Description

Olympus medical systems corp. (omsc) was informed that during two times of surveillance culturing conducted by the user facility, the microbes were detected as follows from the subject device: 1st - 1 cfu / 200ml (chromobacterium) and 2nd - 2 cfu/200ml (staphylococcus coagulase negative). The facility had been manually reprocessed the subject device using peracetic acid and hypochlorite. The user facility reported that this device was reprocessed according to the instruction manual. There was no report of infection associated with this report.

 
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Brand NameOES CYSTONEPHROFIBERSCOPE
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 Key7185177
MDR Text Key97668805
Report Number8010047-2018-00035
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 01/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/12/2018
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 Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
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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