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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-P7
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus service operation repair center (sorc). Sorc checked the subject device and found that the reported phenomenon was duplicated. Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. The exact cause of this event could not be conclusively determined. Olympus medical systems corp. (omsc) surmised that the reported phenomenon occurred since the foreign material that entered the instrument channel from the outside could not be sufficiently removed due to insufficient cleaning and rinsing.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user that during the unspecified timing, the user found the instrument channel of the subject device was clogged with the foreign material (stone). The event date was unknown. Other detailed information was not provided. There was no report of patient injury associated with the event.
 
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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 Key13072892
MDR Text Key284816244
Report Number8010047-2021-16712
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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