MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. FIBERSCOPE "HYF-XP"; HYSTEROFIBERSCOPE

Model Number	HYF-XP
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has 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 sterilization and disinfection (cds) processes performed at the user facility.The detergent used was anios¿clean excel d.The instrument/suction channel, suction cylinder, instrument channel port and distal end were brushed.The disinfectant used was anios¿clean excel d.The device was stored in horizontal storage.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported that, during reprocessing, the hysterofiberscope tested positive for 1 colony forming units (cfu) of staphylococcus hominis on (b)(6) 2023.The device was tested positive again on (b)(6) 2024, for 5 colony forming units (cfus) of neisseria spp.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
Correction to h10 of the first supplemental report.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2024.Sampling from: all channels.Cfu: <1cfu.Bacterial identification: n/a.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist, results of third-party testing, the device evaluation and the lms final investigation.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: feb 06, 2024 sampling from: all channels cfu: >1cfu bacterial identification: n/a 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 the ifu before repair, the results conformed to the regulation's recommendation.The instruction manual of the subject device 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: FIBERSCOPE "HYF-XP"
• Common Device Name: HYSTEROFIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18637347
• Report Number: 9610595-2024-02381
• Device Sequence Number: 20856200
• Product Code: HIH
• UDI-Device Identifier: 04953170411571
• UDI-Public: 04953170411571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K891451
• 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,Followup
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: HYF-XP
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 03/19/2024
• Initial Report FDA Received Date: 02/03/2024
• Supplement Report FDA Received Date: 03/19/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2007
• 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