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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-V2", EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
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 an additional microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the all the channels of the subject device. The testing result cleared the (b)(6) guideline. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. 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, the sample collected from all the channels of the subject device tested positive for staphylococcus lugdunensis (3 cfu / 150 ml) and staphylococcus epidermidis (9 cfu / 150 ml). The testing result does not clear the (b)(6) guideline. The subject device had been reprocessed with a non-olympus automated endoscope reprocessor, soluscope 4, using peracetic acid. There was no report of infection associated with this report.

 
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Brand NameVIDEOSCOPE "CYF-V2", EUROPEAN VERSION
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
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 Key8397579
MDR Text Key138360648
Report Number8010047-2019-01206
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 03/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2014
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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