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

Model Number	BF-H1100
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, the image sensor unit and the circuit board in the endoscope connector may have had anomalies, leading to the subject event.The plug unit and the vent-valve were observed to be corroded.The subject events can be detected and prevented by implementing in accordance with the following ifu.Important information ¿ please read before use precaution: caution turn the video system center on only when the endoscope connector is connected to the video system center.In particular, confirm that the video system center is off before connecting or disconnecting the endoscope connector.Failure to do so can result in equipment damage, including destruction of the image sensor.Precautions for disappeared or frozen endoscopic image: warning follow the precautions given below.Otherwise, the endoscopic image may disappear unexpectedly or the frozen image may not be restored during the examination.3.8 inspection of the endoscopic system inspection of the endoscopic image confirm that the wli, nbi, and rdi endoscopic images are normal.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Olympus will continue to monitor the field performance for this device.
Event or Problem Description
It was observed during the device inspection that the brinchovideo scope exhibited no image and error message e226 (scope communication error).There were no reports of patient involvement.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21450430
• Report Number: 9610595-2025-80033
• Device Sequence Number: 18127608
• Product Code: EOQ
• UDI-Device Identifier: 04953170424229
• UDI-Public: 04953170424229
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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: Other
• Device Model Number: BF-H1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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