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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The referenced device was returned to the manufacturer for evaluation. The service group confirmed the reported spots on the image, from excessive broken image fiber bundles. A visual inspection was performed on the scope and found the bending section skeleton at the distal end of the scope was protruding out from the bending section cover. The bending section damage is approximately 70mm from the distal end side, which failed the leak test from the bending section cover. The bending section cover was removed in order to reveal the extent of the damage to the bending section. Upon removal of the bending section cover, it was confirmed that the bending section skeleton is fully separated producing sharp edges near the insertion tube side. The bending section support pins are still intact and not lifting. Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress, attributed to mishandling. The instruction manual states the following; ¿do not twist or bend the bending section with your hands. Equipment damage may result¿. 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.
 
Event Description
The manufacturer was informed that during preparation for use, the scope was found to have spots in the image. There was no patient harm 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 Key8866337
MDR Text Key205202250
Report Number8010047-2019-02857
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 08/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2019
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 Manufacturer07/10/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/10/2019
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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