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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation. 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
Olympus medical systems corp. (omsc) was informed that as a result of microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device. An unspecified microbe (2 cfu/washing) pantoea septica (8 cfu/membrane filtration) moraxella osloensis (6 cfu/2 membrane filtration) the device had been reprocessed a non-olympus automated endoscope reprocessor, innova e4 using glutaral. The service department of the service department of olympus europe se & co. Kg (oekg) checked the subject device and found the following. The leakage from the insertion tube lock/free knob the damage of the bending section rubber adhesive there was no report of infection associated with this report.
 
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Brand NameVIDEOSCOPE "URF-V"
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 Key10972510
MDR Text Key227200796
Report Number8010047-2020-10067
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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