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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 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report 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 subject device. [first time; (b)(6) 2020] escherichia coli, bacillus licheniformis and bacillus circulans (the total cfu of the escherichia coli, bacillus licheniformis and bacillus circulans is 3 cfu/endoscope) [second time; (b)(6) 2020] unspecified microbes (1 cfu/endoscope) other detailed information such as the reprocessing method was not provided. There was no report of infection associated with this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. 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 microbiological testing. As a result of the testing, no microbe was detected from the sample collected from the all channels of the device. The testing result cleared the (b)(6) guideline. 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.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. Olympus medical systems corp. (omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-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 Key9840678
MDR Text Key222854712
Report Number8010047-2020-01800
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,health professional,u
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2018
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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