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 were 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).

Manufacturer Narrative

The device has been received and is pending evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2024-00002.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the third-party culture testing, device evaluation, and the legal manufacturer's final investigation.Please note: the physical device was returned to olympus, and the evaluation was documented under related record (patient identifier #(b)(6).However, since this complaint is related and involves the same subject device, d9, h3, and h6 have been updated to reflect the device evaluation.The physical device evaluation is as follows: 1.Heavy residue around the bending section cover (a-rubber).2.Residue around the objective lens (ob).3.Heavy residue around the light guide lens.4.Residue in the insertion tube.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been about 2 years since the subject device was manufactured.Olympus sent the subject device for third-party culture testing, and the reported microorganism (pseudomonas) was not detected.However, an unknown number of bacteria, bacillus thuringiensis, was detected in the device¿s insertion section.An olympus representative conducted an onsite visit and identified that the facility did not follow the reprocessing procedures recommended by olympus.Therefore, based on the additional findings, it was identified that the subject device is related to the reported patient infection.Per olympus expert review, it was determined that inadequate reprocessing resulted in large amounts of foreign material on the endoscope which likely caused the patient infection.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual¿.This supplemental report includes additional information added to b5.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 d9 and h3.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the subject scope was cleaned and disinfected after the procedure, prior to returning the device to olympus for testing and evaluation.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18432637
• MDR Text Key: 331863053
• Report Number: 3002808148-2024-00047
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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
• Patient Outcome(s): Required Intervention