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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was inspected at olympus (b)(4). It was could be confirmed the reported phenomenon. It was found that the bending tube of the subject device kept angulated in down direction due to deformation of the bending tube. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection at olympus (b)(4), it was found that the angulation of the subject device became locked and could not disengaged. The subject device had been returned for repair of malfunctions of image and angulation lock. The occurrence date of the event is unknown. 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 Key12931126
MDR Text Key283496667
Report Number8010047-2021-15532
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/02/2018
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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