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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 04/27/2020
Event Type  malfunction  
Manufacturer Narrative
The equipment was returned unrepaired at the customer request. A supplemental will be submitted if additional information becomes available following investigation. An olympus (b)(6) capa has been opened to manage the actions related to remediation of this late mdr reporting.
 
Event Description
The device was returned to the olympus repair center by the customer. During evaluation, the repair center found deterioration of the angulation mechanism due to rust. There was no patient involvement; the reportable malfunction was found during service.
 
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Brand NameOES URETERO-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 Key10943373
MDR Text Key219507420
Report Number8010047-2020-09807
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/20/2021
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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