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

Model Number	CYF-5A
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, during reprocessing, the oes cystonephrofiberscope tested positive for 2 colony forming units (cfus) of microorganism revivable at 30 degrees c.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.
Additional Manufacturer Narrative
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.The device evaluation found: the insertion part of the connecting tube coating was peeled off.The control unit grip unit painting was peeled off.The control unit channel mount was damaged.The control unit mouth guard piece for endoscopy was damaged.The control unit suction cylinder was damaged.The insertion part of the image guide bundle had fiber breakage.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.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.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 the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.As a result of confirming the contents of the instruction manual about shipping products, there are descriptions about reprocessing on the chapters below: chapter 3 compatible reprocessing methods chapter 4 reprocessing workflow for endoscopes and accessories chapter 5 reprocessing the endoscope (and related reprocessing accessories) chapter 6 reprocessing the accessories chapter 7 reprocessing endoscopes and accessories using an aer/wd 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: 17712282
• Report Number: 3002808148-2023-09593
• Device Sequence Number: 20520413
• Product Code: FAJ
• UDI-Device Identifier: 04953170339424
• UDI-Public: 04953170339424
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032092
• 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): 10/19/2023

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-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• 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