MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, during a diagnostic bronchial ultrasound procedure, the new balloon had fallen off the evis eus ultrasound bronchofibervideoscope and was retrieved.No patient harm reported.The facility believed that the balloon may have been too small in diameter for the scope.No additional information was provided.This complaint is related to patient identifier (b)(6) (evis eus ultrasound bronchofibervideoscope, bf-uc190f).
Additional Manufacturer Narrative
In speaking with olympus technical support via the phone, no troubleshooting was performed.The customer called to report the complaint.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to handling by the user might have contributed to the event by the balloons might have not deflated completely when the endoscope was withdrawn from the patient.It is also likely the balloon was not lubricated.The event can be detected/prevented by following the instructions for use (ifu) which state: ·observe the endoscopic image or the ultrasonic image on the video monitor and confirm that the balloon deflates properly.Otherwise, patient injury may occur.·if the balloon does not deflate even when the extension tube is removed from the endoscope, insert the channel cleaning wire (bw-16c) into the irrigation port to remove debris.The balloon will be automatically deflated.·always lubricate the balloon before insertion.Otherwise, the balloon could rupture or come off.This could result in patient injury.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured in september 2021, though a specific date was not identified.The device history record was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14172620
• Report Number: 8010047-2022-06821
• Device Sequence Number: 20319510
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2022

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: 19K
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 06/06/2022; 07/07/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/06/2022; 07/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE
• Patient Sex: Unknown