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	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic endobronchial ultrasound (ebus) procedure, under general anesthesia, the maj-1351 balloon fell off into the patient's airway.The balloon was retrieved with disposable biopsy forceps (model# fb ¿ 211d olympus) right after the scope was removed and the missing piece was discovered.The procedure was completed with the same device without a delay and no unplanned diagnostic test was required.No reports of patient harm.Reportedly, there was no problem with patient's extubating process or recovery.This event is for the balloon.The complaint is related to the patient identifier (b)(6).
Event or Problem Description
No additional information received from the customer.Updated field d4.

• 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: 22332411
• Report Number: 2429304-2025-00187
• Device Sequence Number: 15526076
• Product Code: PSV
• UDI-Device Identifier: 04953170463938
• UDI-Public: 04953170463938
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025
• Report Date (Section F): 11/03/2025

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
• Device Lot Number: 42K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F (BRONCHOFIBERVIDEOSCOPE); BIOPSY FORCEPS, MODEL # FB ¿ 211D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/03/2025