MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Failure to Clean Adequately (4048)

Patient Problems Fever (1858); Nausea (1970); Pain (1994); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

The customer reported to olympus that four patients had urinary tract infections post cystoscopy cases using cystonephrofiberscope.The provider was concerned that the scopes were not being reprocessed correctly before patient use.As reported, the customer had been leaving scopes overnight in a container before reprocessing.A leak had been identified in one scope that was used on three out of the four infected patients.The scopes have not been tested for microbial contamination.The patients had body fluid cultured and presented symptoms of fever, nausea, and pain.There were no reports of further patient or user harm associated with this event.Patient identifiers: (b)(6) - cyf-5 (b)(6) (patient infection).(b)(6) - cyf-5 (b)(6) (leaking scope and patient infection).(b)(6) - cyf-5 (b)(6) (leaking scope and patient infection).(b)(6) - cyf-5 (b)(6) (leaking scope and patient infection).This report is for (b)(6).

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00229.This device has not been returned for evaluation.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 the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.On july 12, 2023, an olympus endoscopy support specialist (ess) recommended improvement in facility layout and flow.The facility is very small with no official reprocessing room.The scopes are reprocessed at bedside in the patient procedure rooms directly after the patient procedures.Ess recommended improvement in general reprocessing.The user is not following the guidelines or recommendations as stated in the olympus reprocessing manual.The users do not have the proper equipment or enough scopes to reprocessing adequately.Ess recommended improvement in transportation and storage.The users do not have a storage cabinet and scopes are hung at the end of a day in a clear plastic tube that is not clean, or placed in a chuck (plastic pad) on the counter in patient procedure room.Ess recommended improvement in equipment handling practices.Many scopes were damaged or leaking, there where scopes left in containers with other instruments and accessories.Ess recommended improvement in physician scope handling/procedural use.Most of the physicians were not engaged or involved in the in-services.Ess has been told by the user that they do not have the ability to properly reprocess scopes as stated in the olympus reprocessing manual due to patient volume and lack of scope inventory.Ess recommends follow up cleaning, disinfection and sterilization in-service, repair reduction in-service, more scopes be purchased, invest in new repressing equipment, and a storage cabinet.Additionally, on july 12, 2023, an olympus ess was dispatched to observe the user facility¿s reprocessing practices from start to finish and to provide a cleaning, disinfection and sterilization in-service training, if necessary, to correct and address any reprocessing deviations.The detailed in-service covers: precleaning, leak test with handheld leakage tester, manual cleaning with high-level disinfection, rinsing, alcohol flush, and proper storage.Ess demonstrated and educated staff on the recommended reprocessing steps listed in the olympus reprocessing manual.Ess also recommended that they store the unused scopes in a drying cabinet or clean the containers that they are hanging them in, overnight with high level disinfectant.Ess advised that the customer to send in the leaking scope to olympus as soon as possible for repair and to stop using the scope.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 phenomenon "four patients were infected" occurred due to the reprocessing procedure deviates from the instruction manual.However, the root cause of the phenomenon could not be determined.Additionally, the device was not returned and the root cause of phenomenon "customer left scopes overnight in a container before reprocessing" could not be identified based on the facts obtained.The event can be prevented by following the instructions for use which state: ¿ chapter 3 compatible reprocessing methods ¿ chapter 4 reprocessing workflow for endoscopes and accessories ¿ chapter 5 reprocessing the endoscope olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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: 17414431
• MDR Text Key: 320216455
• Report Number: 3002808148-2023-07651
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2018
• 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): Other