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	08/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2023-00298.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that during endobronchial ultrasound procedure, the balloon fell off the scope and fell into the laryngeal mask airway tube.The balloon was retrieved, and the procedure was completed.Request for additional information was made, however, unsuccessful.There were no reports of patient or user harm associated with this event.
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 reported event (detachment of balloon) could not be determined.However, the event was likely caused by the following device user handling issue: 1.It was possible that the balloon did not deflate completely when the endoscope was withdrawn from the patient.2.The balloon was not lubricated.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿never tie the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.

• 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: 17788570
• Report Number: 9614641-2023-01353
• Device Sequence Number: 6319821
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 08/24/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown