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

Model Number	UM-G20-29R-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during preparation for use an image abnormality of the ultrasonic probe was discovered.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing the following was found: there is leakage of ultrasonic medium due to the perforation of the tip sheath.This report is being submitted for the malfunction found during evaluation (liquid leakage).
Additional Manufacturer Narrative
The device was returned to olympus and the customer¿s complaint was confirmed, the ultrasonic image is not drawn normally.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is presumed that an event has occurred in which the ultrasonic image is not rendered normally because the ultrasonic wave cannot be transmitted normally due to the leakage of the ultrasonic medium caused by the perforation of the tip sheath and due to the decrease in the ultrasonic medium and the bubbles entering the inside.It is presumed that a hole was made in the sheath at the tip due to some external force, leading to leakage of the ultrasonic medium.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 01581-4003 ; 5082077661
• MDR Report Key: 16311189
• Report Number: 3002808148-2023-01136
• Device Sequence Number: 7048760
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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 PREMIER PLUS.
• Patient Sex: Unknown