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

Model Number	UM-S20-17S
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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 post-reprocessing inspection, the technician found red liquid present inside the ultrasonic probe sheath.Subsequent examination by the customer detected no kinks or structural defects in the catheter probe.No patient use was associated with this event.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected data: d4.The serial number provided by the customer (b)(6) was later found to correspond to an mu-1 maintenance unit, not the subject device reported probe.The serial number was updated to "unknown." the customer later confirmed the probe had been discarded, preventing physical return and evaluation.As a result, the device history record (dhr) could not be located, and the date of manufacture could not be determined.The technical assistance center (tac) spoke to the customer and clarified that the um-s20-17s/ultrasonic probe is an ultrasound radial probe that does not collect tissue samples.The distal tip is sealed and contains ultrasonic propagation fluid with an internal rotating transducer mechanism.The customer was guided through the user manual for proper reprocessing instructions.The customer confirmed that olympus reprocessing steps were followed, using intercept detergent for pre-cleaning and rapicide for disinfection.The device was not returned to olympus for inspection; therefore, the reported presence of red liquid inside the sheath could not be confirmed.As the device was unavailable for physical evaluation, a definitive root cause could not be determined.The most probable cause of the reported event has been categorized as cause not established, as the investigation findings do not provide a definitive conclusion regarding the cause of the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 24403514
• Report Number: 3002808148-2026-04851
• Device Sequence Number: 9748336
• Product Code: ITX
• UDI-Device Identifier: 04953170467301
• UDI-Public: 04953170467301
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown