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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 Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for an evaluation. A visual inspection was performed on the returned device and found the skeleton is broken about 5mm from the base of the bending section area and is exposing metal outside the cover with no sharp edge. The elements inside the bending section are still connected together regardless of the broken skeleton. Additionally the bending section cover has evidence of stretching at the tip of the distal end. Based on the evaluation, service center was able to confirm the user¿s complaint as the cause to the broken bending section skeleton exposing metal is due to excessive force which is attributed to mishandling. The instruction manual it states ¿do not twist or bend the bending section with your hands, equipment damage may result¿. The bending section was manipulated and the movement is abnormal due to the broken skeleton at the base of the bending section. The scope purchase resale date was on february 28, 2018 and the last time the scope came in for service was july 3, 2019 for a 28f refurbishment. The leak test cannot be performed due to the broken bending section.
 
Event Description
The service center received a device for repair for the report of visible damaged along the main stem, the flexible part was crushed. No other event information has been provided by the user facility.
 
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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 Key8848424
MDR Text Key216316860
Report Number8010047-2019-02773
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2019
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 Manufacturer07/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2019
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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