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

Model Number	MAJ-233
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
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 the balloon3 had a tear when coming off the endoscope.Tearing resulted in small rim of rubber remaining on the scope which is nearly invisible to the naked eye as natural rubber on silver colored metal.There were no reports of patient harm.
Event or Problem Description
The event occurred during preparation of use.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 (other and country should remain blank) the device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was discarded, and a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use which state: after checking the contents of the instruction manual (drawing number ge5938:bf-uc180f, revision number 31), the following warning was issued.·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.·the balloon can tear easily, beware of sharp objects.·do not remove the balloon with equipment such as forceps, needle holder, or hemostat that may scratch the surface of ultrasonic transducer.Doing so could damage the ultrasonic transducer and/or cause the ultrasonic image to be abnormal.·picking up the balloon with a clean lint-free cloth makes it easier to remove the balloon.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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18997974
• Report Number: 9614641-2024-00778
• Device Sequence Number: 16858385
• Product Code: ODG
• UDI-Device Identifier: 04953170360428
• UDI-Public: 04953170360428
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2024

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-233
• Device Lot Number: UNKNOWN
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/26/2024
• 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