MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time it is unknown whether the device will provided for evaluation.However, should additional information be provided prior to the investigation completion, a supplemental report will be submitted.
Event or Problem Description
It was reported, an olympus balloon device was not properly staying fixed to the scope.According to the initial reporter, the physician was having difficulty with the balloon rolling off the end and not staying on the scope properly.At this time there was no report of patient harm or consequence as a result of this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Multiple attempts to obtained additional information from the customer have been made without response.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, it is likely this event was caused by user handling.Since the balloon is lot-produced, the same phenomenon is expected to occur frequently within the same lot.The complaint history review did not confirm a trend.As a result, it is presumed that the event was caused by the balloon not being attached correctly, or mounting was not performed in accordance with the method described in the instruction manual.The instructions for use of maj-1351 was reviewed and the following description was given which can prevent the event: "[how to use] 1.Inspect the sterilization pack and the appearance of the balloon; 2.Attach the balloon to the tip of the ultrasonic endoscope using a balloon applicator.".

• 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: 11296679
• Report Number: 8010047-2021-02380
• Device Sequence Number: 4830973
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 04K
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1