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

Model Number	MAJ-249
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, a balloon fell off inside of a patient.The issue occurred during a diagnostic endobronchial ultrasound (ebus) procedure.There was no delay and when the problem was noticed the balloon was retrieved, the device was pulled and the procedure ended.The last part of the procedure wasn't completed, but enough specimens had been collected prior to the balloon falling off.There were no reports of harm to the patient's health.
Additional Manufacturer Narrative
This report is related to patient identifier (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under mdr report number 2429304-2024-00202.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (g2).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, it is likely that the reported event occurred due to the scope cannot be combined with this balloon was used.However, the subject device was not returned, and the root cause could not be identified.The event can be detected/prevented by following the instructions for use which state: "never tie the elastic opening of both sides of the balloon with a thread.This may cause the balloon to rupture or detach from the distal end of the endoscope when inflating it, and could result in patient injury." "never inflate the balloon to a diameter of more than 20 mm when using the endoscope in the trachea.This could result in suffocation of the patient." "never withdraw the endoscope while the balloon is still inflated.Otherwise, the balloon may burst or detach from the distal end of the endoscope.If the balloon cannot be deflated, insert the channel cleaning brush (bw-7b) into the irrigation port.Using slow, short strokes, carefully feed the brush to remove debris." "when withdrawing the endoscope, make sure that the balloon is completely deflated, using the ultrasonic image and endoscopic field of view.Withdrawing the endoscope while the balloon is inflated could result in patient injury." "always lubricate the balloon before insertion.Otherwise, the balloon could rupture or come off.This could result in patient injury." "deflate the balloon before withdrawing the endoscope from the patient.Withdrawing the endoscope while the balloon is inflated could result in patient injury." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the previous submissions.The lot number provided in the initial medwatch was incorrect.Since the lot number of the subject device is unknown, the field has been updated accordingly.Also, a correction has been made to h6 to provide codes that were inadvertently not included in the previous submission.

• 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: 18926791
• Report Number: 9614641-2024-00719
• Device Sequence Number: 14597262
• Product Code: ODG
• UDI-Device Identifier: 04953170360442
• UDI-Public: 04953170360442
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010591
• 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,Followup
• Report Date (Section B): 08/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-249
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 08/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/21/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 90 KG