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

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, during reprocessing, the cystonephrofiberscope tested positive for 2 colony forming units (cfus) of kocuria rhizophila.All channels were sampled.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The suspect device has not yet been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are pending.The customer provided the cleaning, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure.Air/water was aspirated through the instrument/ suction channel with a suction pump.The forceps elevator was moved to raise and lower 3 times in water during aspiration.Aspiration was done with both the 1st and 2nd position of the suction valve.The air/water and balloon channels were flushed with water and air.If manual cleaning was not performed within 1 hour after the procedure, pre-soaking was performed.The device did pass the leak test.During manual cleaning, the suction channel, the suction cylinder, and the instrument channel port was brushed, and the detergent used was anios clean excel.The forceps elevator was raised and lowered three times when submerged in the detergent solution.The forceps elevator was flushed.The distal end was brushed with the channel-opening brush and single use soft brush.The distal end was flushed.The device was rinsed before manual disinfection.The disinfectant used was anioxyde 1000 and the channels were flushed with sterile water.The automated endoscope reprocessor (aer) used was soluscope 4 with anios detergent and soluscope paa disinfectant.The water quality was water filtered and the filter was replaced periodically in accordance with the instructions for use.The device was dried by application of filtered compressed air and stored in a drying cabinet.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information including the legal manufacturer's final investigation, the device evaluation results, and the results of the additional microbiological testing performed.Additionally, (d9) returned to manufacturer date was added, (h3) device evaluated by manufacturer was updated to yes, (h4) device manufacturer date was added.The hygiene microbiological investigation report results indicated the channels of the scope were cultured and <1 colony forming unit (cfu) of microbes were found.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.The device was returned to olympus for evaluation, and no abnormalities in the parts related to where the bacteria was initially detected were found.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation and the information provided, the cause of the bacteria initially detected could not be determined.From the reprocessing information provided by the customer, there were no obvious deviations from the instruction manual.Therefore, the relationship between the device and the initially detected bacteria could not be identified.The event can be detected/prevented by following the instructions for use: olympus cyf-5 olympus cyf-5r reprocessing manual provides detailed instructions.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: 18360250
• MDR Text Key: 331191120
• Report Number: 3002808148-2023-14500
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170292323
• UDI-Public: 04953170292323
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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: ANIOS CLEAN EXCEL, ANIOXYDE 1000; ANIOS PAA DISINFECTANT; MAJ-1444, MAJ-629, MAJ-1888, MAJ-2319; SOLUSCOPE 4, ANIOS DETERGENT