MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO FIBERSCOPE; RHINO-LARYNGOFIBERSCOPE

Model Number	ENF-GP2
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the rhino-laryngo fiberscope tested positive for 14 colony forming unit (cfu) of bacillus subtilis on (b)(6) 2022, tested positive for 7 and 3.Colony forming unit (cfu) of bacillus sp on (b)(6) 2022, and tested positive for 7 and 3.Colony forming unit (cfu) of bacillus sp on (b)(6) 2022.All channels were sampled.The issue was found during a routine culture of the scope.Sampling was taken at reprocessing, before use.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
The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.The device tested positive for one (1) colony forming unit of unspecified micro-organisms.The obtained results are in conformance with the requirements.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.The first cleaning with irrigation of the canals swabbing and soaking in detergent disinfectant solution for 15 mins.The scope was then rinse and drain.For second cleaning, soaked in detergent disinfectant solution for 5 mins.The scope was then rinse and drain.The test strip checked ¿ok¿.Then soaked in anioxy twin disinfectant solution for 15 mins.The scope was then rinse with filtered water.The scope was dry in a medical air drying and storage in a champs sterile storage cabinet.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.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.After checking the content of enf-gp2 ifu, reprocess means are described below: 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: RHINO-LARYNGO FIBERSCOPE
• Common Device Name: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15555794
• Report Number: 3002808148-2022-02872
• Device Sequence Number: 15078439
• Product Code: EOB
• UDI-Device Identifier: 04953170399282
• UDI-Public: 04953170399282
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181240
• 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): 12/07/2022

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: ENF-GP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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