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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to olympus medical systems corp. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Event Description
Olympus was informed that the subject device tested positive for unspecified bacteria during microbiological testing by the facility. The number of the microbes and the position of the subject device, where the microbes were detected, was not reported. There was no report of patient infection associated with this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the additional microbiological testing by the user facility. In the additional test, the testing indicated no microbial growth for the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. Omsc reviewed the manufacture history of the device and confirmed no irregularity.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code".
 
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Brand NameFIBERSCOPE "URF-P5", SET E
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key7640804
MDR Text Key112861918
Report Number8010047-2018-01229
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 company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? No Answer Provided
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

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