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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE

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AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE FLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE Back to Search Results
Model Number URF-V2R
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceFLEXIBLE VIDEO URETERORENOSCOPE, REUSABLE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA 965-8520
Manufacturer Contact
masaharu hirose
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8-520
JA   965-8520
426422891
MDR Report Key15088591
Report Number9610595-2022-00214
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170343612
UDI-Public04953170343612
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2018
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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