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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 Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 08/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. Service confirmed the immobility of the angulation control lever due to foreign material caught in the mobile part of the control section. The device has been repaired and is pending return to the customer. An olympus brazil capa has been opened to manage the actions related to remediation of this late mdr reporting.
 
Event Description
The customer returned the device the olympus repair center. During evaluation, the repair center identified an issue with the device's angulation control lever due to foreign material caught in the mobile part of the control section. There was no patient involvement; the issue was identified during service.
 
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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 Key10909156
MDR Text Key227214712
Report Number8010047-2020-09477
Device Sequence Number1
Product Code FGB
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 01/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
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?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2018
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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