MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE); FORCEPS/ IRRIGATION PLUG

Model Number MAJ-891

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

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

The event is associated with cyf-vh which was reported under the following identifier: (b)(6).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that patient developed pseudomonas urinary tract infection following cystoscopy.The customer reported that the facility was not dismantling and cleaning the cysto-nephro videoscopes and the forceps/irrigation plug correctly.The facility was not taking off the valves and cleaning.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.

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).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.The device history record was unable to be reviewed for this device since the serial number was not provided.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 is possible the suggested event occurred due to insufficient reprocessing due to the users misunderstanding and the deviation from instructions for use (ifu).However, because the user culture results were not shared and the subject device not returned, 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: -cyf-vh/vhr reprocessing manual chapter 1 general policy 1.2 importance of reprocessing."the medical literature reports incidents of cross-contamination resulting from improper reprocessing.It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment." -maj-891 instructions chapter 5 reprocessing: general policy 5.1 instructions: "the medical literature reports incidents of patient cross contamination resulting from improper cleaning and disinfection or sterilization.It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national." - ifu of cyf-vh instructs to detach maj-891 at precleaning as follows: - cyf-vh/vhr reprocessing manual 5.3 precleaning the endoscope."flush the instrument channel with water: loosen the locking ring, detach the forceps/irrigation plug (isolated type) (maj-891) from the endoscope, and place it in the container with the detergent solution." - ifu of cyf-vh and maj-891 instructs to dismantle maj-891 for proper reprocessing as follows: - cyf-vh/vhr reprocessing manual 6.2 manually cleaning the accessories.- disassembling the forceps/irrigation plug (isolated type) (maj-891)."warning: disassemble the forceps/irrigation plug before reprocessing.Otherwise, the forceps/irrigation plug may not be properly reprocessed." - maj-891 instructions 7.3 disassembling the forceps/irrigation plug: "warning: be sure to disassemble the forceps/irrigation plug before it is cleaned, disinfected or sterilized.Otherwise, the forceps/irrigation plug may not be properly cleaned/disinfected/sterilized." olympus will continue to monitor field performance for this device.

Event Description

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.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: FORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
• Type of Device: FORCEPS/ IRRIGATION PLUG
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18409306
• MDR Text Key: 331495942
• Report Number: 9610595-2023-20450
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170063114
• UDI-Public: 04953170063114
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K912120
• 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: MAJ-891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/30/2024; 03/26/2024
• Supplement Dates FDA Received: 01/31/2024; 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: CYF-VH.
• Patient Outcome(s): Other