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

Model Number	MAJ-233
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, that the physician elected to use balloon3 which contains latex on a patient with latex allergy.There was no reportable malfunction of the device and no report of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.H3 other text : device not returned.
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 no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The device was not returned to olympus; therefore a root cause is unable to be confirmed.Additionally, it was confirmed that the patient did not incur an allergic reaction.The event can be detected/prevented by following the instructions for use which state: "balloons used with this instrument contain natural rubber latex which may cause allergic reactions in some patients.Do not use the balloon on a latex-sensitive patient.Instead, perform the procedure using ¿the sterile de-aerated water immersion method¿ described in section 4.2, ¿observation of the ultrasonic image¿." olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information indicates the event occurred during a diagnostic endoscopic ultrasound procedure.The procedure was completed without delay.

• 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: 18243742
• Report Number: 9614641-2023-01815
• Device Sequence Number: 17787575
• Product Code: FDF
• UDI-Device Identifier: 04953170360428
• UDI-Public: 04953170360428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 34K
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GASTROVIDEOSCOPE, 7921896, GF-UE160-AL5.
• Patient Sex: Unknown