MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch report mw5181872 received and reported the following: patient was undergoing a bronchoscopy using an endobronchial ultrasound bronchoscope (ebus).At the end of the procedure, it was identified that the ebus balloon was missing.The patient underwent an additional bronchoscopy x 2, endoscopy x 1 and ct of chest with no retained balloon identified.Additional information was received from the customer: the initial procedure was completed with the same device and was prolonged for approximately one hour to search for the missing balloon.The reported problem no affect the diagnostic outcome of the procedure.This report is 1 of 2.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 24492080
• Report Number: 2429304-2026-00027
• Device Sequence Number: 13430978
• Product Code: PSV
• UDI-Device Identifier: 04953170360459
• UDI-Public: 04953170360459
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/02/2026
• Report Date (Section F): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F ULTRASOUND BRONCHOFIBERVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Race: White
• Date Report Sent to FDA: 03/02/2026