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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 Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation.The customer¿s complaint was confirmed as leaking was observed from the channel at distal end and the scope body.The angulation was checked and found the control knob restricted.The scope was found to be badly corroded while disassembly due to fluid invasion.
 
Event Description
The service center was informed that the scope was noted to have a leak at the tip.There was no patient involvement reported.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-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 Key10617529
MDR Text Key223662044
Report Number8010047-2020-07100
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403385
UDI-Public04953170403385
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2020
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 Reuse
Patient Sequence Number1
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