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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  malfunction  
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.
 
Event Description
It was reported by the customer, after a microbiological routine culture on the uretero-reno fiberscope, an unexpected contamination was detected. There was no reported contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
 
Event Description
Additional information was received from the reporter. All channels were sampled. The uretero-reno fiberscope tested positive for one (1) colony forming unit (cfu) of staphylococcus epidermidis.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter and the cleaning, disinfection, and sterilization (cds) checklist performed by the customer. The cleaning, disinfection, and sterilization (cds) was performed by the customer. There was no patient infection. The sampling was routine. The automatic endoscope reprocessor (aer) was sampled/cultured, however the test report was not available. The flushing of the air/water channel, auxiliary water channel, and forceps elevator wire channel were precleaned without detergent. The instrument/suction channel, instrument channel port, and the distal end/areas around the elevator were manually cleaned with olympus bw-400b single-ended cleaning brushes. The scope was not manually disinfected. The scope was however disinfected with anioxyde 1000 disinfectant every procedure. The scope was not sterilized. The maintenance was performed by olympus.
 
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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 Key12923104
MDR Text Key284615651
Report Number8010047-2021-15475
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/25/2018
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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