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)
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus employee reported on behalf of the customer the balloon came off the evis eus ultrasound bronchofibervideoscope, fell into the patient and required retrieval during an ebus procedure.In addition, the user had difficulty passing the needle during the biopsy.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The subject device was not returned to olympus, therefore, the reported phenomenon and condition of the device could not be confirmed.A review of the device history record (dhr), found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of this phenomenon could not be identified.The likely cause of the balloon detachment is the balloon might have not deflated completely when the endoscope was withdrawn from the patient and/ or the balloon was not lubricated.The instruction manual (drawing number rc8193:bf-uc190f, revision number 2), warns the following: never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 come off the distal end of the endoscope.If the balloon cannot be deflated, insert the channel cleaning brush (bw-400b) into the irrigation port.Using slow, short strokes, carefully feed the brush to remove debris.After that, the balloon can be deflated.When withdrawing the endoscope, make sure that the balloon is completely deflated, using the ultrasound 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 the field performance of this device.This report has been submitted by the importer under this mdr report number 2429304-2023-00187.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17094464
• Report Number: 9614641-2023-00824
• Device Sequence Number: 7690625
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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
• Device Lot Number: 2ZK
• 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: 05/11/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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: BF-UC190F, SN (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown