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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V3
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2019
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 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 all 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 the subject device tested positive (8947 cfu / 100 ml) and the testing result indicated that there were no indicator microbes.The device had been manually reprocessed using peracetic acid.There was no report of infection associated with this report.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-RENO 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 Key8419644
MDR Text Key140021330
Report Number8010047-2019-01272
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-V3
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/18/2019
Initial Date FDA Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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