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

Model Number	UM-3R
Medical Device Problem Code	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
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 after the ultrasonic probe was cleaned and disinfected during reprocessing, yellow liquid adhered when the probe device was wiped with gauze.The yellow liquid adhered even after wiping it off several times.The facility's cleaning method is as follows: cleaning using endopure, immersion in disopa, flushing with water, and wiping with disinfectant ethanol solution b ip on gauze.Yellow liquid adhered at the last step in the cleaning process.There was no patient involvement.There was no report the device was used in a procedure.
Event or Problem Description
No additional information was received by the customer.
Additional Manufacturer Narrative
The subject device was returned for device investigation.Additional information: h3, and h6.The customer allegation of yellow liquid was confirmed.The device evaluation performed an analysis of the yellow fluid and confirmed that its internal components were proteins, fatty acid salts, and hydrocarbon compounds and that it did not contain any ultrasonic probe components.We have confirmed that fatty acid salts (calcium stearate) are components of surfactants and lubricants and that they may have originated from products used in the vicinity of cleaning agents.Based on the results of the investigation, the definitive root cause could not be determined.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: 21712275
• Report Number: 3002808148-2025-05339
• Device Sequence Number: 15938094
• Product Code: ITX
• UDI-Device Identifier: 04953170063213
• UDI-Public: 04953170063213
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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-3R
• 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: 03/27/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
• Patient Sex: Unknown