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)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Urinary Tract Infection (2120)

Event Date 11/05/2023

Event Type  Injury  

Event Description

The customer reported to olympus that there have been incidents whereby patients were getting infections (urosepsis) due to not dismantling and cleaning the cysto-nephro videoscopes correctly and they are not taking off the valves and cleaning.The patients underwent cystoscopy.One patient had passed away due to this, as reported.Six developed a blood stream infection, five of which were directly linked to the scopes.Forty-two developed pseudomonas urinary tract infections (see report numbers below) and the customer is currently investigating if there is any link to the scopes.The cystoscopes are not in use currently.This event required five reports for the confirmed infections with the following 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.(b)(6)- 6/6 patient infection.It is unknown which patient identifier was associated to the one patient that passed away.(b)(6) will be used as representative to report for the patient death.Request for additional information has been made, however, no new information has been received at this time.This medwatch report is for patient identifier (b)(6).Additionally, please refer to the following related patient identifiers for the 42 alleged pseudomonas utis: (b)(6).

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on results of the legal manufacturer's final investigation.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 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, it was confirmed that reprocessing of the device was insufficient due to the facility¿s deviation from the instruction for use (ifu) manual.However, a relationship between the subject device and the reported adverse event (urinary tract infection) could not be identified.The device was not returned to olympus for evaluation, and no further event details, nor device culture test data was provided by the facility.Therefore, a root cause could not be determined.Furthermore, the following was determined regarding insufficient reprocessing: the incorrect reprocessing of the concomitant device (maj-891) 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 detected/prevented by following the ifu in section: ¿cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual¿.-describes the reprocessing procedures of cyf-vh.This supplemental report includes additional information from the customer.B5 updated accordingly.Also, a correction has been made to b5, d4, and d10 from the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the circumstances regarding the patient infections were still under investigation at the facility; however, the tests involving the forceps/irrigation plug (maj-891) concluded that there was biofilm present in the rubber bung.The customer reported that this likely contributed to the reported events.The customer stated that they will not be using the maj-891 device and using only the single use options at this time.In addition, the customer will only use third-party disposable scopes and will not use the suspected scopes until the internal investigation is completed by their facility.Furthermore, the customer confirmed that there are no concerns regarding the olympus scopes used at the facility.As previously noted, the reported issue is related to the hospital¿s internal cleaning process.The customer stated that they are aware that some elements of the scope have intricate pieces and can therefore be difficult to decontaminate.Although additional information was requested, the facility stated that they will not be providing any further information regarding this event.

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 (march 26th & 27th 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: 18388041
• MDR Text Key: 331290136
• Report Number: 3002808148-2023-14796
• 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: 04/25/2024

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: 04/05/2024; 04/25/2024
• 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