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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed that it was found that the coating of the insertion tube had been partially peeled off more than 4mm during the incoming inspection for the repair of the subject device at olympus (b)(4). The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device was returned to (b)(4). (b)(4) checked the subject device and found the reported phenomenon, and also found that this phenomenon was attributed to the deterioration. The exact cause has been under investigation. Therefore, the exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
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Brand NameFIBERSCOPE "URF-P5", SET E
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12960511
MDR Text Key285460004
Report Number8010047-2021-15748
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2017
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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