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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-P7
Device Problems Device Reprocessing Problem (1091); Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
The customer reports during routine microbiological testing on an uretero-reno fiberscope (as required by (b)(6) regulations, the customer detected unexpected contamination. There was no patient impact related to this occurrence.
 
Manufacturer Narrative
The device referenced in this report will be returned to olympus for repeat cultures and physical evaluation/inspection. The definitive cause if the user's experience cannot be determined at this time. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
 
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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 (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA 965-8520
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13245258
MDR Text Key293440696
Report Number8010047-2022-01372
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2019
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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