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

Model Number	UM-G20-29R-3
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the customers allegation was confirmed.It was noted that there were holes, dents and scratches on the tip sheath.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 likely that the following led to the malfunction: (1) ultrasound image does not come out.·since there is a hole in the tip sheath and the ultrasonic medium leaks out, it can be seen that the ultrasonic medium has decreased.Since the ultrasonic medium is reduced, it is presumed that the ultrasonic wave cannot be transmitted normally and the ultrasonic image cannot be drawn normally.(2) there is a hole in the tip sheath, and there is leakage of the ultrasonic medium.·it is presumed that some kind of stress was applied to the tip sheath, causing the tip sheath to break and become perforated.A definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): as a result of checking the instruction manual and the labeling of the product, there were no abnormalities leading to the phenomenon.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported to olympus, that the ultrasonic probe ultrasonic images were not available during pre use inspection.The issue was completed with a similar device.Inspection and testing of the returned device found that there was a hole in the tip sheath and the ultrasonic medium leaked.There were no reports of patient harm associated with this event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

• 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: 17491253
• Report Number: 3002808148-2023-08164
• Device Sequence Number: 18099498
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• 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