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	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- address- the full name of the establishment is (b)(6).The hygiene microbiological investigation (hmi) results were provided.The results reported the device channel (all channels) tested positive with the following: samplings dates and results: (b)(6) 2023-4 cfu of an unspecified microbes; (b)(6) 2023 -3 cfu of an unspecified microbes; (b)(6) 2023- 19 cfu of an unspecified microbes.The olympus france french olympus subsidiary for hygiene microbiological investigation (hmi) performed a culture test for the device after the device was reprocessed.The results reported device channel (all channels) conforms to results of <1 cfu/100 ml and <1 cfu/endoscope (microorganism revivable).The results obtained comply with the target level defined in the regulations of france outlined on (b)(6) 2016.The results are conform to french recommendation.The device was then returned to regional repair center (rrc) olympus for evaluation.Device evaluation, the following were noted: bending section (a-rubber) cementing noted.Broken control unit f-knob.Mouthpiece deformed.Image check light guide fiber dots noted.Additional information: customer cds checklist noted no suspected patient infection, no deviations or deficiencies in their reprocessing.Device was quarantined as soon as positive culture was identified and not used with any other patients.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, after a microbiological routine control test on the subject medical device as required by french regulation, the user detected an unexpected contamination.The issue found during reprocessing.The customer then left the device to the olympus france (ofr) french olympus subsidiary for hygiene microbiological investigation (hmi) for further investigation.No report of any contamination or any patient injury or patient infection to which this medical device could have been a contributory cause.No user injury reported.
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 the 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 "reprocessing workflow for endoscopes and accessories" chapter "reprocessing the endoscope".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: 17432992
• Report Number: 3002808148-2023-07743
• Device Sequence Number: 18367306
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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