MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number	CYF-VA2
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.An olympus representative interviewed the facility where it was stated the following cleaning disinfecting and sterilizing process was deviated from in the following ways: the outer surface of the insertion site for flexible cystoscope products in the bedside cleaning described in the instruction manual after the examination were not wiped, the bedside cleaning did not describe the instruction manual for flexible cystoscope products after examination that involves pumping water into the channel using a suction device and the endoscope's suction valve, the user is not cleaning the adapter and suction machine to suction cleaning solution, water, and air during main cleaning and rinsing for flexible cystoscope product with suction ducts, the inside of the channel was not filled with cleaning and disinfection solution by aspirating the cleaning and disinfection solution with a syringe through the suction cleaning adapter during immersion in the endoscope at the time of main cleaning and disinfection, the t-pipe was not cleaned and disinfected as described in the instruction manual, the t-pipe has not disassembled as described in the instruction manual, if the forceps plug of the t-pipe has deteriorated due to use and was not properly replaced as described in the instruction manual, and the t-pipe was not cleaned with the brush as described in the instruction manual.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the cysto-nephro videoscope was incorrectly reprocessed.There were no reports of patient harm or injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, it is likely the event occurred because the facility did not reprocess the subject device properly because they performed reprocessing with the procedures different from in the instruction manual.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be prevented by following the instructions for use: chapter 5 reprocessing: general policy.Chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Chapter 8 compatible endoscope reprocessor.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: CYSTO-NEPHRO VIDEOSCOPE
• 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: 20433525
• Report Number: 3002808148-2024-09876
• Device Sequence Number: 20730451
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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-VA2
• Was Device Available for Evaluation?: No
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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