MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number	CYF-5
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported that, during reprocessing, the cystonephrofiberscope tested positive for 47 colony forming units (cfus) of staphylococcus lugdunensis, staphylococcus haemolyticus, and staphylococcus epidermidis (all channels were sampled).The device was sampled again on june 4, 2024 and tested positive for 1 cfu of an unspecified microorganism (all channels were sampled.The device was sampled again on (b)(6), 2024 and tested positive for 1 cfu of acinetobacter radioresistens and staphylococcus saprophyticus (all channels were sampled).The user did not report any contamination or any other serious deterioration in the state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of third-party testing, the device evaluation and the lms final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.Additional information: d8, d9, h3, h4, h6, h11.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: on (b)(6) 2024.Sampling from: all channels.Cfu: <1 cfu/endoscope.Bacterial identification: n/a.The device was evaluated where no abnormalities were found that could have led to the reported 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 the ifu after repair, the results conformed to the regulation's recommendation.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Common Device Name: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20418591
• Report Number: 3002808148-2024-09801
• Device Sequence Number: 8295666
• Product Code: FAJ
• UDI-Device Identifier: 04953170292323
• UDI-Public: 04953170292323
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown