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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORPORATION URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2014
Event Type  malfunction  
Event Description
Olympus medical system corp.(omsc) was informed that at the time the user facility started f-tul procedure and treatment, no image and image difficulties broke out.The user facility operated the monitor, but the image was not improved.Since the user facility did not have a backup scope, the procedure was aborted.There was no patient harm reported.
 
Manufacturer Narrative
The subject device was returned to omsc for evaluation.Evaluation confirmed the reported phenomenon of no image and image difficulties as the video-connector was moved slightly.No air leak was detected and no irregularities of outer appearance were found in the video-connector and video-connector substrate.And also, no irregularities were found in soldering of the video-connector, electrical connection, wiring, surface of electrical cables and resistivity.As electrical connection was changed to connect the video-connector to a different substrate, the image became normal.As a result of the evaluation, omsc concluded that there was a breakage of the video-connector substrate.The manufacturing history was reviewed, with no irregularities related to this problem noted.This report is being submitted as a medical device report in an abundance of caution.
 
Manufacturer Narrative
Olympus medical systems corporation (omsc) performed a mdr retrospective review and found that this supplemental report is required on (b)(6) 2015.The conclusion of this issue is no different from the initial report.This report is being submitted as a medical device report in an abundance of caution.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA  192-8507
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
26425177
MDR Report Key4188668
MDR Text Key5160684
Report Number8010047-2014-00520
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/08/2016
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-V
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/09/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/29/2014
Initial Date FDA Received09/26/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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