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

Model Number	CYF-VHR
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during the therapeutic cystoscopy, debris from the cysto-nephro videoscope fell into the patient's bladder.There was a procedural delay while the doctor tried to basket the debris out but could not catch the debris in the non-olympus basket.The patient urinated the debris out and is in good standing.Another cystoscopy was performed last week.The procedure was completed successfully and the outcome was not affected as a result of the issue.The device was inspected before use and appeared to be normal.

• Brand Name: 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
• MDR Report Key: 19403927
• Report Number: 2429304-2024-0000274
• Device Sequence Number: 15150107
• Product Code: FAJ
• UDI-Device Identifier: 04953170434730
• UDI-Public: 04953170434730
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2024
• Report Date (Section F): 04/29/2024

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-VHR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2024
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK BASKET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown