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

Model Number CYF-VHA

Device Problem Contamination (1120)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device evaluation 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 that there was an increase in the number of infections about a year ago and the director felt it was 10-20 people.Some patients were admitted to other hospitals with fever during the night and on saturdays and sundays.A culture test on the device was not performed.The event was reported after use of the cysto-nephro videoscope.Additional information regarding patient symptoms, diagnosis, and treatment was requested, but the customer declined to provide it.This report is for patient 18 of 20.

Manufacturer Narrative

This report is being supplemented to provide the device evaluation results and the findings from the onsite visit by an olympus endoscope support specialist (ess).The subject device was evaluated by olympus, and no reportable abnormalities were identified.The visual check could not confirm if the subject device was related to the reported infection.On 29may2024, an olympus ess conducted an onsite visit and confirmed that the facility¿s reprocessing procedures were inadequate.Per the ess, the cleaning and disinfecting of the devices were insufficient, as foreign matter adherence was observed within the forceps of the device.The results of the confirmed deviations from the instructions for use (ifu) manual are as follows: pre-cleaning of the endoscope and a leak test was not performed.Cleaning of the external surface was only partially performed, and not in accordance with the ifu.Brushing of all the channels was not performed.Aspirating a cleaning solution through the forceps and suction channel was performed insufficiently.Immersion of endoscope and suction cleaning adapter in a cleaning solution was not performed.Although water was pumped by a syringe, the removal of a cleaning the cleaning solution was performed insufficiently.Drying of external surfaces was not performed.Although an alcohol flush was performed, it was not done in accordance with the ifu.Finally, the device was only partially cleaned.Furthermore, after the reported infection outbreak, a replacement device was lent to the facility.It was noted by the facility that the number of patients complaining of symptoms of infection decreased sharply after the replacement device was provided.This supplemental report also includes additional information received from the customer.B5 updated accordingly.A correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.Also, an update has been made to h3 and h6.The investigation is still ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported by the facility that there have been no more health hazard reports since receiving the replacement device.Also, there have been no reports that any of the involved patients are still hospitalized or have residual injuries related to the infections.

• 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: 18950545
• MDR Text Key: 338253461
• Report Number: 3002808148-2024-02678
• 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: 03/21/2024

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-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
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/21/2024
• 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): Hospitalization