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

Model Number	UM-G20-29R
Medical Device Problem Codes	Residue After Decontamination (2325); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s final investigation.Additional data: d8, h3.It has been over 5 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.The yellow substance was tested and it consisted of protein, fatty acid salt, and hydrocarbon compounds, and they did not contain any components of the ultrasound probe.Based on the results of the investigation, a definitive root cause could not be established.It is likely the following led to the malfunction: - fatty acid salts (calcium stearate) are components of surfactants and lubricants, and it was thought that they might have originated from those used in cleaning agents and other products.- hydrocarbon compounds might have turned yellow due to lubricating oil (components containing mineral oil and paraffin oil).The event can be detected/prevented by following the applicable chapters in the instructions for use which state: chapter 3 preparation, inspection and operation.3.2 inspection.2.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protrusions, bends, leakage of ultrasonic propagation fluid or other irregularities.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional customer information.
Event or Problem Description
It was reported the ultrasonic probe was wiped after reprocessing and sterilization and the gauze had an unidentified yellow liquid.There was no patient involvement.There was no report the device was used in a procedure.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 21689155
• Report Number: 3002808148-2025-05028
• Device Sequence Number: 13088325
• Product Code: ITX
• UDI-Device Identifier: 04953170368578
• UDI-Public: 04953170368578
• Combination Product (Y/N): N
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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-G20-29R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2019
• 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