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

Model Number	CYF-5A
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to e1.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, phenomenon 1 "foreign body in the illumination lens" was confirmed however the foreign body in particular could not be confirmed and it was unclear whether the cleaning process was performed correctly however a probable cause could not be confirmed.Additionally, it is likely that phenomenon 2 "the forceps insertion part was broken, and the forceps was pulled out with too much force during cleaning" was caused by mishandling by customer.The event can be detected/prevented by following the instructions for use which state: chapter 7 cleaning, disinfection and sterilization procedures chapter 8 cleaning and disinfection equipment olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed during the olympus device evaluation the cystonephrofiberscope exhibited a detached forceps channel insertion port and foreign objects in the light guide (lg) lens.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus and evaluated.The foreign material found has been attributed to insufficient cleaning.The customer provided the following details regarding device handling: they did perform cleaning, disinfecting, or sterilizing processes on the device before sending it in for repair.The customer did not know the nature of the foreign material.During pre-cleaning: precleaning was not delayed or skipped.During manual cleaning/reprocessing: it is unknown if there are any abnormalities in the accessories used for reprocessing.The distal end was wiped or brushed with clean, lint-free cloths, brushes, or sponges.In addition to the reportable malfunctions of detached forceps channel insertion port and foreign objects in the light guide (lg) lens, the evaluation found non-reportable malfunctions of device component wear, discoloration, stickiness, corrosion, breakage, and damage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• 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: 18729768
• Report Number: 3002808148-2024-01502
• Device Sequence Number: 8191826
• Product Code: FAJ
• UDI-Device Identifier: 04953170292521
• UDI-Public: 04953170292521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2018
• 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