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

Model Number	MAJ-1351
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the balloon had tiny holes in it.The issue was found during a bronchoscopy endobronchial ultrasound procedure, during which the balloons were placed at the end of the bronchoscope.The issue impacted the duration of the procedure; however, there were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found the device was manufactured in october 2023.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: the balloon can easily tear, so beware of sharp objects.Store the balloon in a cool environment with low humidity.After opening the laminate package, reseal it securely.If the laminate package remains open, the efficacy of the deoxidizer will be reduced.Attaching the balloon: prepare the balloon and the balloon applicator.Inspect the balloon and confirm that it has no holes, no swelling, no color changes, or no other irregularities.If an irregularity is detected, do not use the balloon; use a spare instead, inspecting it thoroughly before use.Grab the tip of the balloon with the applicator.Fold the rear band back onto the applicator.Position the rear band onto the groove of the applicator.Open the applicator wide enough to fit the ultrasound transducer of the endoscope into it.Insert the ultrasound transducer of the endoscope into the balloon.Put the rear band of the balloon into the rear balloon groove of the endoscope.Then, move the applicator down, away from the distal end of the endoscope.After performing the steps above, the balloon should be attached to the scope.Fill the syringe with sterile de-aerated water or saline.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20383418
• Report Number: 9614641-2024-01944
• Device Sequence Number: 6465288
• Product Code: PSV
• UDI-Device Identifier: 04953170360459
• UDI-Public: 04953170360459
• Combination Product (Y/N): N
• 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): Unknown
• 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): 11/20/2024

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: Health Professional
• Device Model Number: MAJ-1351
• Device Lot Number: 3XK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male