MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.According to the reporter the subject device was not available for return.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that during preparation for use, the ebus balloon was found with a leak to the side of the unit showing that it was broken.The intended procedure was completed with another similar device.The lot/ serial number of the device used was not provided.There was no patient impact or harm was reported due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.It is presumed that the reported issue likely caused by handling after shipping the product.As stated on the instructions for use and as a preventive measure: balloons are easily broken.Do not poke the balloon by using a sharp object, and handle it with great care.Olympus will continue to monitor complaints for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Visual inspection of the returned balloon under a microscope found no abnormalities, no holes.The small band and large band appeared to be normal.Furthermore, to check for leakage, the balloon was installed on the distal end of the test ultrasonic endoscope bf-uc180f.The balloon openings fitted tightly and properly into the grooves, no looseness could be felt.When water was injected from the test syringe, observed no water leaking out from the balloon during balloon inflation.Based on investigation, the reported complaint was not duplicated.The balloon passed the inspection.Olympus will continue to monitor complaints for this device.

• 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: 10466137
• Report Number: 8010047-2020-05975
• Device Sequence Number: 2889266
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2021

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: 02K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 02/05/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/21/2020; 02/08/2021
• Patient Sequence Number: 1