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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 Problems Break (1069); Melted (1385); 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 service center for an evaluation. A visual inspection was performed and found the bending section skeleton protruding out from the cover. The bending section damage is approximately 70mm from the distal end side, which is also causing a leak. The bending section cover was removed in order to reveal the extent of the damage. Upon removal of the cover, it was confirmed that the bending section skeleton is fully separated producing protrusion near the insertion tube side. The bending section support pins are still intact and not lifting. Further findings include a burn on the distal end body, leak from the distal end body, and broken fibers scattered throughout the image. Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress attributed to mishandling. Followed up with the user facility in writing to obtain additional information regarding the reported event was performed multiple times with no additional information to date. The instruction manual states the following warnings statements; ¿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 in a narrow environment".
 
Event Description
The customer returned the scope indicating the image was black during the procedure. No other details have been provided. This report is being submitted based on the service findings of the distal end rubber leakage and the bending section found broken with the metal exposed and protruding.
 
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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 Key8828030
MDR Text Key152824533
Report Number8010047-2019-02708
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 07/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2019
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 Manufacturer07/08/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2019
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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