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

Model Number	MAJ-1351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An olympus representative reported to olympus on behalf of the customer that the balloon fell off the evis eus ultrasound bronchofibervideoscope into the patient during an unspecified procedure.The balloon was retrieved.There was no harm or user injury reported due to the event.The customer was unable to provide more information.This event is reported under the following patient identifiers: (b)(6) - balloon, (b)(6) - bronchofibervideoscope.

• 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
• MDR Report Key: 16924200
• Report Number: 2429304-2023-00086
• Device Sequence Number: 17875132
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2023
• Report Date (Section F): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1351
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F/UNKNOWN SERIAL NUMBER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown