MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
The customer reported that several balloons burst during a procedure.These failed balloons are the same lot.There was no report of patient injury associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Un-packed seven pieces of maj-1351 were returned to olympus medical systems corp.(omsc) for evaluation, and no scratches or holes were confirmed.Omsc confirmed that the lot of the subject device was manufactured in december, 2019, and reviewed the device history record (dhr).There was no abnormalities which related to the reported phenomenon were found.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the investigation results of similar phenomenon in the past, there was the possibility that the reported phenomenon, balloon burst, was attributed to the user handling as follows; - the ends of the balloon were tied with thread and the balloon ruptured when over-inflated.- the balloon was forcefully withdrawn from the scope when it was not deflated.
Event or Problem Description
This supplemental report is being submitted to provide additional information about the event.The user facility further reported the followings: the user inspected the device before the procedure to confirm that the device was normal.The reported event that the several balloons burst was found during an endobronchial ultrasonography (ebus) in the anesthetized patient.The first balloon burst inside the patient.The balloon or its fragments were successfully removed with forceps.The user replaced the baloons to another balloons of a new pack and the procedure was completed.The procedure took longer than planned, but the procedure did not lead to any serious deterioration of the patient's health condition.If additional information becomes available, this report will be supplemented.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10676653
• Report Number: 8010047-2020-07668
• Device Sequence Number: 3028231
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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: No Information
• Device Model Number: MAJ-1351
• Device Lot Number: 9ZK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 12/01/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/13/2020; 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1