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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

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AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2
Device Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was received and evaluated. Device evaluation and inspection , service repair noted the angle locks. Both the curved rubber and the curved tube found damaged. The angle locks due to the break in the angle wire. The customer reported issue was confirmed. Furthermore, the following findings during device evaluation were noted : watertightness not maintained due to holes in the forceps channel due to external factors. The forceps cannot be smoothly inserted into the forceps channel. Liquid leakage observed in the lg (light guide) bundle due to handling. There are scratches on the insertion part, operation part, grip, rotation mechanism, angle lever, video cable, video connector, light guide connector, up/down angle fixing lever due to external factors. Corrosion due to water leakage observed in the operation part. Watertightness not maintained due to holes in the curved rubber caused by external factors. Sw1 (switch #1 ) found not working. Liquid leakage observed in the grip up/down plate , universal cord due to handling. Wrinkles are found in the universal code due to external factors. The index peeling of the rotation mechanism found. The video connector case found difficult to remove due to handling. Investigation is ongoing. This report will be supplemented accordingly following investigation.
 
Event Description
Customer reported with an issue of the angle has stopped moving. The issue found during an unknown event. There was no patient harm, no user injury reported due to the event. Device evaluation found the angle locks (angulation locking malfunction. Angulation becomes locked-cannot disengage) due to damage, break in the angle wire.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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 Key15055352
MDR Text Key303065849
Report Number9610595-2022-00099
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170343582
UDI-Public04953170343582
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172246
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 09/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Was the Report Sent to FDA? No
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2018
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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