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

Model Number CYF-VH

Device Problems Contamination (1120); Failure to Clean Adequately (4048)

Patient Problem Bacterial Infection (1735)

Event Date 11/30/2023

Event Type  Injury  

Event Description

The customer reported to olympus, three patients became infected with pseudomonas after the cysto-nephro videoscope was used on them for a diagnostic cystoscopy.The event occurred in the operating room, emergency room, and gastrointestinal lab.The infection started in november and the patients are better after receiving intravenous (iv) antibiotics.The intended procedure was completed for each patient.The patient's anesthesia was not extended as a result of the issue and the outcome of the procedures was not affected.The device was inspected prior to use on each patient per the instructions for use (ifu) and was replaced during the event.Related patient identifiers: (b)(6).

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: 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: 18432536
• MDR Text Key: 331863202
• Report Number: 2429304-2024-00001
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023,01/02/2024

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
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2023
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention