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

Model Number	CYF-5
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, there was an increasing number of urinary tract infections and prostatitis after cystoscopy using the cystonephrofiberoscope.The last four patient's have subsequently been diagnosed with a nosocomial infection.The customer has performed over 850 cystoscopies since the beginning of 2020 and in the last 3 to 4 weeks they have noticed something might be wrong.The reprocessing of the flex cystoscope is carried out in exactly the same way as it has in the beginning of 2020.The last hygiene inspection in the beginning of 2024 did not reveal any deficiencies.The facility has paid more attention to the preparation when they realized this, but nothing has changed.The internal controls are still in order, even after the nosocomial infections.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This medwatch is related to the following patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, device evaluation, and results of third-party testing.The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported patient infection.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, the relationship between the device and the infection to the patient cannot be determined.Culture test at the facility could not be obtained.However, third-party culture testing was performed (per olympus), and bacteria were not detected.Additionally, since no bacterial contamination of the device was detected, olympus conclude that the device has been reprocessed correctly and cleaning disinfection and sterilization (cds) processes were not obtained.The event can be detected/prevented by following the instructions for use which state: cyf-5 has reprocessing manual, and it described reprocessing procedure.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: 19638690
• Report Number: 3002808148-2024-05934
• Device Sequence Number: 12542319
• Product Code: FAJ
• UDI-Device Identifier: 04953170292323
• UDI-Public: 04953170292323
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K221690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown