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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
On july 13, 2020, olympus medical systems corp. (omsc) received literature titled "pre-use ureteroscope contamination after high level disinfection: reprocessing effectiveness and the relation with cumulative ureteroscope use". In the literature, it was reported that the result of the microbiological test using olympus endoscope and non-olympus endoscope from december 2015 to december 2017. And, in the postoperative period, the adverse events of urinary tract infection symptoms were reported in 25 of 389 procedures. It was not reported that a direct relationship between the subject device and the observed adverse events. It was reported that the subject device or other device was used with the procedure. Therefore, it was not identified which device was used for the related procedure. Therefore, omsc will submit a medical device report (mdr) for the type of adverse event of the subject device. In contrast, as a result of the microbiological testing, the following microbes were detected. Urf-v2 (2 scopes) : uropathogens (10 cfu/ml or greater) urf-v2 (7 scopes) : skin flora (30 cfu/ml or greater) urf-p6 (4 scopes) : skin flora (30 cfu/ml or greater) there was no other information about the infection in this literature. Based on the available information, other detailed information such as the number of microbes and serial number was not provided. Therefore, omsc will submit 13 medical device reports (mdr) depending on the number of endoscopes. This report is 13 of 14 reports. (this is a report about the microbiological testing).
 
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Brand NameURETERO-RENO FIBERSCOPE
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 Key10354715
MDR Text Key224661033
Report Number8010047-2020-05171
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
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 Received07/13/2020
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 Reuse

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