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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-V
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Further evaluation of the device confirmed the customer¿s reported leaks and found that they were due to perforations in the bending section cover (a-rubber). An air leak was also observed due to damage of the rotation mechanism (adjustment ring). The bending angle was lacking due to elongation of the angle wire. The adhesive of the bending section cover was chipped. The video connector was deformed and discolored. The video cable was scratched, and the video connector cover was cracked. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time. If additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The customer reported that the flexible part of the subject device was leaking in two places. There was no patient or user injury reported due to the event. The subject device was returned to an olympus service center for evaluation. During inspection and testing, service found the light guide lens had detached. This report is being submitted for the malfunction found by service (light guide lens detached).
 
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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 Key15066711
MDR Text Key303830754
Report Number9610595-2022-00128
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340321
UDI-Public04953170340321
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2022
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2009
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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