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

Model Number	UM-S20-17S
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during the onsite visit the endoscopy support specialist (ess), noted that the user facility does not have the appropriate monitoring strips nor temperature monitoring set up for their high-level disinfectants on the ultrasonic probe.The issue was found during reprocessing for an onsite visit.There was no report of patient involvement.
Additional Manufacturer Narrative
Updated: b5, h2, h6, h11.This report is being supplemented to provide additional information based on the approved final investigation.The product was not returned to olympus for inspection.Based on the results of the investigation, the root cause of the reportable malfunction could not be identified/determined.Additionally, an endoscopy support specialist (ess) was dispatched to the user facility for reprocessing support of the ultrasonic probe.It was noted that the user facility staff did not have the appropriate monitoring strips nor temperature monitoring set up for their high-level disinfectant.The ess spoke with clinical coordinator, and endoscopy technician/ materials coordinator about ordering the thermometer and the disinfectant test strips.Questions answered and education provided on the manual reprocessing of the um-s20-17s, ultrasonic probe.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional issues/malfunctions were found during investigation and were identified/determined to be not reportable.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• 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: 23760235
• Report Number: 3002808148-2025-24714
• Device Sequence Number: 18640232
• Product Code: ITX
• UDI-Device Identifier: 04953170467301
• UDI-Public: 04953170467301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K250762
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: UM-S20-17S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown