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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not described on the literatures. There was no malfunction report of the subject device concerning the events. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
On november 28th, 2018, olympus medical systems corp. (omsc) received a literature titled ¿the treatment results of the flexible transurethral lithotomy (f-tul) in our hospital¿ that was made in public in the 32th congress of japanese society of endourology. The literature reported that 53 procedures of the f-tul were conducted using olympus ureterorenoscope (urf-v) and a non-olympus ureteral access sheath (12 fr or 14 fr). Between june 2014 and april 2018, the f-tul procedures were conducted after antibiotic administration and microbiological culturing test for the urine sample of the patients. The literatures reported that complications occurred as follows; fever (over 38): 4 cases; ureteral injury: 1 case; ureteral perforation: 1 case; renal failure (anuria): 1 case. It was reported that all of the reported complications were not serious injury. Further detailed information such as the relationship between the subject device and all of the reported complications could not been obtained at present. Therefore, according to the number of the type of complications known and the number of device used for procedure, omsc is submitting 4 medical device reports. This is a report on ureteral perforation associated with urf-v and three of four reports.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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 Key8201692
MDR Text Key131703412
Report Number8010047-2018-02579
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,user facility
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
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
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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