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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-P7
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2021
Event Type  malfunction  
Manufacturer Narrative
The cleaning, disinfection, and sterilization (cds) of the scope was performed by the customer. There was no patient infection. The automatic endoscope reprocessor (aer) was not cultured/tested. The air/water channel and forceps elevator channel were flushed with anios clean excel d detergent. The instrument/suction channel and distal end/areas around the elevator were manually cleaned with anios clean excel d detergent and olympus single use single-ended cleaning brushes. The scope was manually disinfected with anioxyde 1000. The scope was stored horizontally in a storage cabinet. The maintenance of the scope was performed by olympus. The scope was not sterilized. 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, on (b)(6) 2021, during a routine microbiological culture of the uretero-reno fiberscope, the biopsy channel tested positive for one (1) colony forming unit (cfu) of microorganisms. On (b)(6) 2022, the biopsy channel tested positive for forty-six (46) cfus of microorganisms. On (b)(6) 2022, the biopsy channel tested positive for three (3) cfus of microorganisms. There was no contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.
 
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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 Key13514399
MDR Text Key285489080
Report Number8010047-2022-02808
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403811
UDI-Public04953170403811
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K181451
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 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2018
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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