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

Model Number CYF-VHA

Device Problem Contamination (1120)

Patient Problems Fever (1858); Pain (1994); Urinary Tract Infection (2120); Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.It was reported there were no problems with equipment handling, and there was no request for facility training.The customer confirmed the device was properly reprocessed in accordance with the instruction manual.The main body, cock, forceps plug, and tightening knob (cap) were all disassembled and were cleaned and disinfected in accordance with the instruction manual.

Event Description

It was reported there was an increase in the number of infections over the course of a year and the director felt it was 10-20 people.The customer contact stated one patient developed infection with klebsiella pneumoniae, an extended-spectrum beta-lactamase (esbl) producing bacteria, after use of the cysto-nephro videoscope for a diagnostic cystoscopy.After the cystoscopy procedure, the patient visited the hospital with complaints of pain during urination and fever, noted to be symptoms of cystitis due to a urinary tract infection.A urinalysis confirmed the bacterial infection and the patient was treated with antibiotics.This report is for patient 1 of 20.

• 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
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18944484
• MDR Text Key: 338160030
• Report Number: 3002808148-2024-02628
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAJ-891
• Patient Outcome(s): Required Intervention