MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOVIDEOSCOPE

Model Number	BF-1TH1100
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and found no detection of any microbes.The results are evaluated in accordance with the joint recommendation of the krinko and the bfarm 'requirements for hygiene in the reprocessing of medical devices' (bundesgesundheitsbl 2012 - 55:).Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
It was reported that the bronchovideoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.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
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, the device evaluation and the lms final investigation.Despite good faith attempts the user culture results were not shared.The lm reviewed the customer provided the cds processes where the following deviation from the ifu was confirmed: -water has not been suctioned during pre-cleaning.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: on (b)(6) 2024.Sampling from: distal end section.Cfu: n.D.Bacterial identification: n/a.Sampling date: on (b)(6) 2024.Sampling from: instrument channel / suction channel.Cfu: 0 cfu/ml.Bacterial identification: n/a.Sampling date: on (b)(6) 2024.Sampling from: instrument channel.Cfu: 5 cfu/ml.Bacterial identification: n/a.Sampling date: on (b)(6) 2024.Sampling from: instrument channel / suction channel.Cfu: 1 cfu/endoscope (3 cfu/100ml).Bacterial identification: micrococcus luteus/lylae.Sampling date: on (b)(6) 2024.Sampling from: total.Cfu: 1 cfu/endoscope (2 cfu/100ml).Bacterial identification: micro organisms revivable at 30.The device was evaluated where no abnormalities were found that could have led to the reported event.Based on the results of the investigation and because the user culture results were not shared, the reported event could not be confirmed and a root cause could not be determined.Growth of microorganisms were reported through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance the following is included in the device ifu: "an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.".Olympus will continue to monitor field performance for this device.

• Brand Name: BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• 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: 20411316
• Report Number: 9610595-2024-20536
• Device Sequence Number: 7892779
• Product Code: EOQ
• UDI-Device Identifier: 04953170424199
• UDI-Public: 04953170424199
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: BF-1TH1100
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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