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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This device referenced in this report has been returned to olympus medical systems corp. For evaluation. During the evaluation, the reported phenomenon was not duplicated. It was confirmed that angulation worked without noise or caught. The subject device passed the water leak test. The manufacturing record of the subject device was reviewed with no abnormality possibly associated with the reported phenomenon. The exact cause of the reported event could not be conclusively determined.
 
Event Description
Olympus was informed that during an unspecified procedure, angulation of the subject device was unable in the down direction. The user replaced the subject device with a similar device and completed the procedure. There was no patient injury reported.
 
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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
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6773042
MDR Text Key82159574
Report Number8010047-2017-01193
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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