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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to an olympus service center for evaluation. Service confirmed the angulation becomes locked due to deterioration of the angulation mechanism by rust. The device is awaiting repair at the service center and will be returned to the customer upon completion. An olympus (b)(4) capa has been opened to manage the actions related to remediation of this late mdr reporting.
 
Event Description
The user facility reported to olympus that there were issues with the bending section of the device. There was no harm or injury reported.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key10981108
MDR Text Key227200522
Report Number8010047-2020-10141
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340802
UDI-Public04953170340802
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2020
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

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