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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Event Description
It was reported by the customer, all channels were sampled, and the videoscope tested positive for eleven (11) colony forming units (cfus) of mesophilic organisms. The issue was found during a routine culture of the scope. There was no contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
 
Manufacturer Narrative
The subject device has been received and is currently in the evaluation process. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time. However, if additional information becomes available this report will be supplemented accordingly.
 
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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 Key12959562
MDR Text Key281910938
Report Number8010047-2021-15742
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340321
UDI-Public04953170340321
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2013
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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