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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-P6R
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The reference device was returned to the service center for a physical evaluation. A visual inspection was performed on the returned device and found the bending section skeleton tab was protruding (sticking out) from the bending section cover near the insertion tube area. The bending section cover was removed and the bending section skeleton was fully broken and separated with no signs of any sharp edges. The protruding skeleton tab was bent. The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿. Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment. This is a newer type ns unit (post counter measure) that was verified by the positioning of the bending section tab. The scope had a 28f (overhaul) on 6/25/2019 from the previous repair. Based on the evaluation, the cause of the broken bending section skeleton and bent skeleton tab is due to excessive force and/or stress attributed to mishandling.
 
Event Description
The scope was returned to the service center for a poor image. During the service estimation the metal protrusion at the bending section of the scope was found. No other details were made available.
 
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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 Key8861153
MDR Text Key194324748
Report Number8010047-2019-02836
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/08/2019
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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