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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-V
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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] instrument channel: roseomonas mucosa (1 cfu/20ml). [second time; (b)(6) 2020] -instrument channel: roseomonas mucosa (1 cfu/20ml). 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, the sample collected from the instrument channel of the device tested positive for mesophilic aerobic bacteria (4 cfu) 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. The followings were confirmed by the evaluation of the subject device. Insertion tube lock/free knob was leaky. Bending rubber was damaged. Control section was corroded. Scope connector was corroded. There were sediments in the scope connector. Universal cord was damaged. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. If additional information becomes available, this report will be supplemented.
 
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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 Key9956136
MDR Text Key208989077
Report Number8010047-2020-02185
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
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 Received05/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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