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

Model Number	MAJ-1351
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	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to (b)(4).
Event or Problem Description
It was reported that during a diagnostic endoscopic bronchial ultrasound (ebus) linear fine needle aspiration (fna), the scope channel was clogged causing an obstruction.The clinician was unable to pass an instrument through the channel and the balloon failed, stating when launching the balloon, it slipped off the scope.The initial pass of the needle was fine, however after several passes, the needle got stuck and would not pass.There was no injury to the patient.While there was a delay, the time is unknown.The intended procedure was not complete.It was aborted and the patient will be rescheduled.The patient was under general anesthesia.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.Additional information received: it was reported, that the balloon was not lubricated.And the balloon was attached using the balloon applicator.The device malfunction occurred, during the end of the procedure.And the subject device was inspected, prior to use.The customer has used the bf-uc190f (ultrasound bronvhofibervideoscope ) before.A endotracheal tube was used, during the procedure.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 user handling could have caused the balloon dropout.It was possible, that the balloons might have not deflated completely when the endoscope was withdrawn from the patient.However, the subject device was not returned.And the root cause of the reported event could not be determined.The event can be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 endoscop,e 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.

• 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: 19733665
• Report Number: 9614641-2024-01429
• Device Sequence Number: 7117661
• Product Code: PSV
• UDI-Device Identifier: 04953170360459
• UDI-Public: 04953170360459
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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-1351
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/07/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F SCOPE. SN (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown