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

Model Number	CYF-5R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Dysuria (2684)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a cystoscopy procedure, a patient reported urinary tract infection (uti) symptoms 2 days after the procedure date with the use of this cystonephrofibroscope.Additional information was received from the customer that the patient exhibited burning sensation with urination, urinary frequency and feeling of incomplete voiding.The patient was then treated with antibiotic for 7 days.There were no culture tests done with the patient and the cystonephrofibroscope.The customer noted it was quite unusual to have utis in that span of time.There were no further reports of patient harm.There was no allegation of device malfunction.This report is for patient 1 of 4.

• 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
• MDR Report Key: 24405487
• Report Number: 2429304-2026-00017
• Device Sequence Number: 18182353
• Product Code: FAJ
• UDI-Device Identifier: 04953170328817
• UDI-Public: 04953170328817
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 02/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2026
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2026