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

Model Number	MAJ-1351
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that he had four olympus balloons that had cracks noted during procedure preparation.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.This is event 3 of 4.For the related cases, please see reports with patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Sections d9, h3, h4, h6, and h10 were updated.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 definitive root cause of the balloon rupture could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ·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.·the balloon can tear easily, beware of sharp objects.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide information with the device return.The subject device was returned but further device evaluation could not be completed.If additional information becomes available, this report will be supplemented accordingly.

• 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: 17450576
• Report Number: 9614641-2023-01077
• Device Sequence Number: 12616560
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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-1351
• Device Lot Number: 0ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 11/15/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/24/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sex: Unknown