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	06/17/2024
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 hygiene microbiological investigation report indicated the channels of the scope were cultured and found that the scope tested positive for greater than 1 cfu of revivable micro-organisms.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.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 contamination during two separate tests.The first tested positive for 1 colony forming unit (cfu) of a revivable micro-organism and 1 cfu of staphylococcus aureus.The second tested positive for 3 cfus of revivable micro-organisms.All channels were sampled.The user did not report any contamination or any other serious deterioration in 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 the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the lms final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Despite good faith attempts, the user culture results, and cleaning disinfection and sterilization (cds) processes were not shared.The results of culture testing by a third-party organization indicates that in both cases, the number of bacteria detected was less than 1 cfu, and it was confirmed that it complies with french regulations.The device was evaluated, and no abnormalities were found that could have led to the reported event.Based on the results of the investigation, the relevance between the device and the detection of bacteria could not be established and a root cause could not be determined.As result of confirming instruction manual, following sections describe reprocessing procedures.They may prevent from the phenomenon.Chapter 4 reprocessing workflow for endoscopes and accessories; chapter 5 reprocessing the endoscope.Olympus will continue to monitor the field performance of 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: 19809553
• Report Number: 3002808148-2024-06753
• Device Sequence Number: 18079980
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 07/01/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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