OES URETERO-RENO FIBERSCOPE URF-P5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-19 for OES URETERO-RENO FIBERSCOPE URF-P5 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[185601162] The subject device was not been returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10


[185601163] Olympus medical systems corp. (omsc) received a literature titled? Clinical study of pcnl and urs for kidney stones with a major axis of 20 mm or more?. The literature reported the result of 31 cases of ureterorenoscopy (urs) between january 2013 and december 2017. There was a possibility that urs was performed using the urf-p5. In this literature, it was reported adverse events as follows: ureteral injury: 2 cases. Fever: 4 cases. Fever (septic shock): 1 case. Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined. Omsc is submitting seven mdrs according to the number of the adverse events. This is 1 of 7 reports. (1 of 2 ureteral injury cases).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2020-01413
MDR Report Key9725604
Report SourceLITERATURE
Date Received2020-02-19
Date of Report2020-02-19
Date Mfgr Received2020-01-23
Date Added to Maude2020-02-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOES URETERO-RENO FIBERSCOPE
Generic NameURETERO-RENO FIBERSCOPE
Product CodeFGB
Date Received2020-02-19
Model NumberURF-P5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-19

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