MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. PROBE DRIVING UNIT

Model Number	MAJ-1720
Medical Device Problem Codes	Break (1069); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the probe driving unit's socket is broken and the image is dark.The ion endobronchial ultrasound under general anesthesia was prolonged for over 30 minutes due to switching of radial probes with the unit and needing to have a biomed technician come up to assist with troubleshooting during the case.There were no reports of further patient harm.

• Brand Name: PROBE DRIVING UNIT
• Common Device Name: PROBE DRIVING UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 21298166
• Report Number: 2429304-2025-00057
• Device Sequence Number: 9245557
• Product Code: ITX
• UDI-Device Identifier: 04953170355684
• UDI-Public: 04953170355684
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/03/2025
• Report Date (Section F): 02/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-1720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROBE
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/03/2025