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U.S. Department of Health and Human Services

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

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AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2022
Event Type  malfunction  
Manufacturer Narrative
Upon inspection and testing of the returned device, the reported issue (leakage from a-rubber) was confirmed and found to be caused due to damaged a-rubber. In addition to a-rubber falling off, service found the bending angle was out of specification due to wear of the angulation wire, the image guide bundle was broken, there was noise during angle operation, and the up down angle fixing lever was cracked. Scratches were observed on the eyepiece unit, and the angle lever due to external factors. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time. However, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
The customer reported there was an air leakage from the bending section cover (a-rubber). The reported issue occurred during an air-check, after the intended procedure was completed. There was no patient/user harm or injury reported due to the event. The subject device was returned to an olympus service center for evaluation. Upon inspection and testing of the returned device, it was observed the a-rubber was broken and fell off. This report is being submitted for the malfunction found during evaluation of the device (a-rubber fell off).
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. Based on the results of the investigation, it¿s likely the reported event (a-rubber broke and fell off) was due to external factors or user handling. The root cause of this event was unable to be identified. Olympus will continue to monitor field performance for this device.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key15089267
MDR Text Key302967518
Report Number9610595-2022-00218
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340802
UDI-Public04953170340802
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172298
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 09/29/2022
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-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2022
Was the Report Sent to FDA? No
Date Manufacturer Received09/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
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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