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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
 
Event Description
Olympus medical systems corp. (omsc) has been made aware of a literature titled ¿comparison of perioperative outcomes of nurse-assisted or one person f-tul conducted by a single physician¿ that was presented at the 32nd congress of japanese society of endourology. The literature reports the result of 52 cases of transurethral ureterolithotripsy (tul) conducted between may 2017 and april 2018 at a user facility, using olympus uretero-reno fiberscope model urf-p5. In the literature, it is reported as adverse events that postoperative febrile urinary tract infections (uti) (nine cases) and a ureteral injury (one case) occurred as a result of the procedures. Moreover, the patient who suffered from a ureteral injury was required to have a stent placement for two months as well as subsequent extracorporeal shock wave lithotripsy (eswl) due to the injury. According to the literature, the perioperative outcomes of the both groups (nurse-assisted or one person f-tul) were equivalent. However, uti frequently occurred in the both groups are compared to reports written by experts. Thus, it is concluded that there is still room for further improvement of tul conducted by the subject physician. Any further detailed information have not been obtained to date. Omsc is submitting mdr according to the number of types of the adverse events. This is two of two reports related to ureteral injury.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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Brand NameOES URETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key8201845
MDR Text Key131592991
Report Number8010047-2018-02593
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Type of Report Initial,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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