MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. BALLOON3

Model Number	MAJ-233
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.The event was conservatively classified as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes.
Event or Problem Description
It was reported that the water balloon was found to be leaking upon installation.This caused a 30-minute delay or greater during a diagnostic endoscopic ultrasound.There were no reports of further patient harm.
Event or Problem Description
No other information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection the reported failure was confirmed: the balloon was leaking, there was a hole in the balloon and no other device malfunction was identified.According to the device's instructions for use (ifu), the balloon is fragile and can easily tear if it comes into contact with sharp objects or is handled improperly.No adverse patient outcome, including death, infection, or injury was reported.A definitive root cause could not be identified.Based on the results of the investigation and the condition of the balloon, the most likely cause of the leakage is user handling, suggesting possible user error.Olympus will continue to monitor field performance for this device.

• Brand Name: BALLOON3
• 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: 21129840
• Report Number: 9614641-2025-00038
• Device Sequence Number: 15372830
• Product Code: ODG
• UDI-Device Identifier: 04953170360428
• UDI-Public: 04953170360428
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-233
• Device Lot Number: 45K(NJOWN)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown