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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 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) received a literature title "steep infundibulopelvic angle as a new risk factor for flexible ureteroscope damage and complicated postoperative course. " the literature reported the result of 381 cases of the flexible ureteroscopy (furs) procedures using an olympus model urf-v (ureteroscope) and fb-56d-1 (biopsy forceps) between september 2013 and march 2017. In the subject procedures, the following cases reportedly occurred. 4 bleeding complication cases. 27 urinary tract infection cases. 5 perforation cases of the upper urinary tract. 2 pneumonia cases. 2 unknown complications. Based on the available information, a direct relationship between the subject devices and the observed reported adverse events could not be determined. According to the number of accidental symptoms and the number of olympus devices used for the procedures, omsc is submitting 10 medical device reports. This report is 7th of 10 reports for unknown complications and urf-v.
 
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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 Key9726303
MDR Text Key192670724
Report Number8010047-2020-01442
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2020
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

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