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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-V2
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2016
Event Type  malfunction  
Manufacturer Narrative
The manufacturing record of the two subject devices was reviewed without irregularity. As a result of culture conducted on the two subject devices by olympus (b)(4) bacteria was not detected. Olympus (b)(4) sent the test result and the two subject device to the user facility. The exact cause could not be determined at present. Omsc is following up with the user facility to obtain additional information regarding the reported event. If significant additional information is received at a later time, a supplemental report will be followed.
 
Event Description
Olympus medical system corp. (omsc) was informed that the facility performed a culture test, and bacteria was detected from unused two urf-v2s. There was no patient infection reported on this event. This report is 1 of 2.
 
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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
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
8142642517
MDR Report Key6134156
MDR Text Key61494963
Report Number8010047-2016-10079
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-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 Received11/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2016
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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