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

Model Number CYF-VH

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The 9 cystoscope serial numbers the facility has on site: (b)(6).The device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A user facility reported that 42 patients developed pseudomonas urinary tract infections (uti).There have been incidents whereby patients were getting infections (confirmed to be urosepsis) as the user facility was not dismantling and cleaning the scopes correctly.Additionally, the facility was not taking off the valves and cleaning.The facility mentioned they have 9 cystoscopes on site, but it is unknown if these were involved in the utis; the facility is investigating if there is a link between the utis to any olympus scope.Training will be conducted at the facility by olympus.Additional information has been requested.The customer also previously reported five patient blood stream infections directly linked to the scopes in the related patient identifiers: (b)(6) - 1/5 patient infection (death).(b)(6) - 2/5 patient infection.(b)(6) - 3/5 patient infection.(b)(6) - 4/5 patient infection.(b)(6) - 5/5 patient infection.Please refer to the following related patient identifiers for the 42 alleged utis: (b)(6).

Event Description

The infection was found after a cystoscopy procedure.The facility had tests conducted on the forceps/irrigation plug which concluded that there was bio film on the rubber bung.The facility stated it was clear that the problem lay with the cleaning procedures that had not been followed in dismantling the forceps/irrigation plug.Training will be conducted at the facility by olympus and the facility will no longer use the current forceps/irrigation plug, but would move to the single use option instead.In the meantime, the scopes would not be used, and rather, disposable scopes would also be used until the facility finished their investigation.The customer contact stated that the causal relationship of the device to the patient outcome is under investigation at the facility.Additionally, the user commented that the problem was not the olympus scopes and was related to the internal cleaning issues at the hospital.Although, some elements of the scope have intricate pieces, and as such can be difficult equipment to decontaminate.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (d10 and e4).Additionally, to provide additional information received through follow up (b5).Based on olympus reviews incorrect reprocessing of the maj-891 created an environment to harbor pseudomonas, which are often pathogenic in large numbers and are frequently associated with urinary tract infections.Despite good faith attempts the user culture results and cleaning disinfection and sterilization (cds) processes were not shared.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is possible the suggested event occurred due to reprocessing deviations from instructions for use (ifu).However, a relationship between the subject device and the reported adverse event could not be identified.Additionally, the user culture results were not shared, and the subject device not returned, therefore; the reported event could not be confirmed, and a root cause could not be determined.The event can be prevented by following the instructions for use which state: ¿cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual¿ -describes the reprocessing procedures of cyf-vh.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information.An olympus representative went onsite to complete training.During the training, it was apparent to the representative that the staff has not familiarized themselves with the reprocessing steps despite being asked to do so prior to the training session.The training was carried out over two dates ((b)(6) 2024) and covered the full team in the endoscopy department, which is the team that are now responsible for the reprocessing of the cyf scopes on site.The training included a hands-on session and the instructions for use steps (located in the manual) were followed.The instructions for use for both devices, cyf scope and maj-891 plug, were used for the training session.The representative also placed a high level of emphasis on the cleaning of the maj -891 irrigation plug.Since the sites are currently using the semi¿reusable plug, a high level of emphasis was carried out in regard to the plug.The olympus representative had spoken to the regional contact for follow-up with the site.Olympus will continue to monitor field performance for this device.

• 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: 18387845
• MDR Text Key: 331286189
• Report Number: 3002808148-2023-14795
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/31/2024; 03/26/2024
• Supplement Dates FDA Received: 02/01/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other