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

Model Number	CYF-5
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the oes cystonephrofiberscope tested positive for an unexpected contamination.The issue was found during regular examination in the hospital.The user did not report any contamination or any other serious deterioration in state of health of any person, to which this medical device could have been a contributory cause.
Additional Manufacturer Narrative
The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Pre-cleaning involved flushing of the channels.Aniosyme x3 was used as the detergent for precleaning and manual cleaning.Manual cleaning involved brushing the instrument/suction channel, suction cylinder, instrument channel port, and distal end.An asept inmed brush was used during manual cleaning.Anioxyde 1000 was used for manual disinfection.The scope was stored horizontally.The scope was sterilized using anioxyde 1000 using the cycle complete sterilization program.Sterilization was done per procedure.Olympus was not used for maintenance and repair.After the device was returned to olympus, it was sent out for additional testing.The microbiological analysis report indicated the channels of the scope were cultured and the results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.During device evaluation at olympus, it was found the bending section cover had a cementing defect, the image guide bundle had spider webs, and the image guide bundle had fiber breaks.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The instruction manual of cyf-5 describes the reprocessing methods in the following chapters: chapter "compatible reprocessing methods and chemical agents" chapter "cleaning, disinfection, and sterilization procedures" olympus will continue to monitor field performance for this device.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Common Device Name: 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: 16910383
• Report Number: 3002808148-2023-04741
• Device Sequence Number: 15343986
• Product Code: FAJ
• UDI-Device Identifier: 04953170434532
• UDI-Public: 04953170434532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: N3821744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 06/03/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown