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

Model Number CYF-VH

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303); Insufficient Information (3190)

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

Event Type  Injury  

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).

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.

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 (b1, b5, d10, and h6 -medical device problem code).Additionally, to provide information received through follow up (b5 and h10 -expert review).Additional information was requested; however, the user facility did not provide the following: patient information including the event details, details of the reprocessing procedure, and culture test data of the device.Although a review of the device history record (dhr) was performed, it only included five of the nine potential scopes used by the facility.Since the serial number involving the scope is unknown, it cannot be determined if a dhr was reviewed for the scope captured in this complaint.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, olympus was not able to judge relation between the subject device and the event from the following investigation results.Additionally, it is likely the reported event occurred because reprocessing was insufficient due to deviation from the instruction manual.The root cause of the reported event could not be determined.Olympus expert reviews: the incorrect reprocessing of maj-891 (forceps/irrigation plug) created a perfect environment to harbor pseudomonas which is an easy biofilm former, a quick reproducer and is often pathogenic in large numbers and very frequently associated with urinary tract infections (utis).The event can be prevented by following the instructions for use which state: ¿cysto-nephro videoscope olympus cyf-vh olympus cyf chr reprocessing manual" olympus will continue to monitor field performance for this device.

Event Description

The following additional information that was inadvertently left out of the initial: 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.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.The following additional information was received: the user confirmed that the problem was not the olympus scopes and was related to the internal cleaning methods performed by the facility.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.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 regards 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: 18387687
• MDR Text Key: 331287099
• Report Number: 3002808148-2023-14760
• 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?: Yes
• 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: 03/29/2024; 03/26/2024
• Supplement Dates FDA Received: 04/02/2024; 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