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
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00187.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.The complaint is related to the patient identifier: (b)(6).
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.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00187.This report is being supplemented to provide additional information based on the final investigation.Updated field : d4, g1, h2, h3, h6 and h11.The date of manufacturer is february 2024 based on the provided 3 digit lot information "42k".Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The most probable cause of the complaint is cause not established, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor field performance for this device.Should additional relevant information become available, a supplemental report will be submitted.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22332424
• Report Number: 9614641-2025-01065
• Device Sequence Number: 20905200
• Product Code: PSV
• UDI-Device Identifier: 04953170463938
• UDI-Public: 04953170463938
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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