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

Model Number	CYF-V2
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported three patients experienced infection after a cystoscopy procedure was performed.Two patients tested positive for klebsiella urinary tract infection and one patient was positive for citrobacter amalonaticus.The patients were treated with antibiotics and the infections subsided.There were no further reports of patient harm.The customer reports following "normal protocol" for sterilization of the device.This report is related to the following linked patient identifiers: (b)(6).

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 20854414
• Report Number: 2429304-2024-01023
• Device Sequence Number: 18728332
• Product Code: FAJ
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2024
• Report Date (Section F): 12/05/2024

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-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/06/2024
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• 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: 12/05/2024