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

Model Number	UM-3R
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the evaluation found scratches on the insertion site and bending on the insertion tip.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause not established.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the ultrasonic probe exhibited scratches on the insertion site and bending of the insertion tip.There was no patient involvement.

• 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: 20226541
• Report Number: 3002808148-2024-36451
• Device Sequence Number: 7174910
• Product Code: ITX
• UDI-Device Identifier: 04953170368561
• UDI-Public: 04953170368561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: Other
• Device Model Number: UM-3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown