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

Model Number	MAJ-1351
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the balloon had a rupture.The issue occurred during preparation for use.The intended procedure was completed with another similar device and there was an approximate 5 minute delay.There were no reports of patient harm.
Additional Manufacturer Narrative
Updated d8, d9, and h3.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, the reported malfunction was reproduced.The likely cause could be that the balloons are very thinly molded and can easily break if excessive force is applied during installation.Stretching the balloon using your fingernail or overstretching it with the applicator are possible causes of balloon breakage.However, a definitive root cause could not be determined.The event can be detected and prevented in accordance with the following instructions for use (ifu).After checking the contents of the instruction manual, the following warning was issued.·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.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of 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: 19610253
• Report Number: 9614641-2024-01326
• Device Sequence Number: 15036505
• Product Code: PSV
• UDI-Device Identifier: 04953170360459
• UDI-Public: 04953170360459
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown