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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 Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
The service center was informed that the uretero-reno fiberscope was returned for a reported image problem. During inspection and testing, the scope was found to have metal protruding from the bending section cover. There was no patient injury or harm reported to olympus.
 
Manufacturer Narrative
The evaluation found the a hole and protruded (metal) skeleton from the bending section cover. The reported image issue was confirmed as the image has excessive broken fibers (black dots). Additionally, the scope failed the leak test due to a large leak from the instrument channel at the distal end. The bending section cover glue is chipped with exposed threading. The objective lens has sunk down and the eyepiece body is discolored. The scope was last serviced via repair on (b)(6) 2019. The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time. However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
 
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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 Key13287734
MDR Text Key284027676
Report Number8010047-2022-01619
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340802
UDI-Public04953170340802
Combination Product (y/n)N
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
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 Manufacturer12/19/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2018
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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