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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 scope was returned to the manufacturer. A visual inspection was performed on the scope and confirmed the excessive broken fibers (black dots) throughout the image. In addition, the bending section skeleton at the distal end was protruding out from the bending section cover. The bending section damage is approximately 70mm from the distal end side, which was leaking from the bending section cover. The bending section cover was removed to reveal the extent of the damage to the bending section; it was confirmed that the bending section skeleton was fully separated producing sharp edges near the insertion tube side. The bending section support pins, were still intact and not lifted. A review of the instrument's history indicates the scopes was last repaired on may 7th 2019. 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¿. The instructions for safe use manual also indicates 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. As part of our investigation, multiple follow ups were made the user facility to obtain additional information regarding the reported event but no information was obtained. If additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The manufacturer was informed that the scope has broken fibers on the image. There was no patient injury 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 Key8873513
MDR Text Key207922948
Report Number8010047-2019-02900
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 08/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2019
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 Manufacturer07/12/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2019
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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