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Model Number URF-P7
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Manufacturer Narrative
After the device was returned to olympus, it was sent out for additional testing. The hygiene microbiological investigation report indicated the channels of the scope were cultured. Less than one (1) cfu of bacteria was found. The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water. 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, auxiliary channel, balloon channel, and forceps elevator channel were flushed with enzymex detergent. There was an aspiration of water through the instrument/suction channel as well. The instrument/suction channel, suction cylinder, balloon channel, instrument channel port and distal end/areas around the elevator were manually cleaned with mediclean forte detergent and olympus single use single-ended cleaning brushes. The scope was sterilized with hydrogen peroxide in a steris v-pro on a flexible cycle weekly. The scope was stored horizontally. The maintenance of the scope was performed by olympus. 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, all channels were sampled during a routine microbiological culture of the uretero-reno fiberscope. The scope tested positive for one (1) colony forming unit (cfu) of coagulase-negative staphylococci. 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.
Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation. The device was evaluated where no abnormalities were found that could have led to the positive culture. A defect was noted where the bending section rubber glue was worn out however, this defect alone is not considered severe enough to cause a potential adverse event. A review of the device history record found no deviations that could have caused or contributed to the reported issue. Based on the results of the investigation, a root cause could not be determined. Growth of microorganisms were found through culture testing by the user after reprocessing. However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation. The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them. " olympus will continue to monitor field performance for this device.
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Manufacturer (Section D)
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
MDR Report Key13514724
MDR Text Key296312269
Report Number8010047-2022-02812
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403811
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
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 Manufactured10/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse