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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-V3
Device Problems Break (1069); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Customer reported with an issue of dry, failed leak test. The issue found during reprocessing. There was no patient harm, no use injury reported. Device evaluation found bending section damaged. The soldered joints exposed (popped out).
 
Manufacturer Narrative
The subject device was received and evaluated. Device inspection and evaluation found the bending section (a-rubber) leaking. The customer reported issue was confirmed. In addition, the bending section found damaged, the soldered found exposed (popped out). Additionally , the following findings were observed : peeling on a-rubber glue observed. Cracked video connector observed. Investigation is ongoing. This report will be supplemented accordingly following investigation.
 
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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 Key15044120
MDR Text Key298967641
Report Number9610595-2022-00061
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403385
UDI-Public04953170403385
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
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 Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
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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