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.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.This report has been submitted by the importer under this mdr report number (b)(4).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the results of the legal manufacturer¿s investigation.Updated fields: h2, h4, and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was returned to olympus for inspection and the reported failure was not confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it was confirmed that there was no problem with the device.Olympus will continue to monitor field performance for this device.
Event or Problem Description
There was no additional information received from the customer.

• 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
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21298271
• Report Number: 3002808148-2025-01737
• Device Sequence Number: 13093392
• Product Code: ITX
• UDI-Device Identifier: 04953170355684
• UDI-Public: 04953170355684
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K011886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROBE
• Patient Sex: Unknown