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

Model Number	UM-3R
Medical Device Problem Codes	Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: non-healthcare professional / company representative.Based on the results of the investigation, a definitive root cause cannot be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The reported risk/harm is addressed in the instructions for use (ifu): ¦6.3 observations (caution): do not push or pull the ultrasonic probe with strong force or pull it into the endoscope curvature while the ultrasonic probe is driven (unfrozen state).In particular, push and pull the ultrasonic probe slowly when the endoscope is strongly bent or when forceps are being raised.Strong force or sudden movements may cause image distortion or damage to the ultrasound probe.When driving the ultrasound probe, return the endoscope curvature and forceps raising as much as possible.Driving with a harsh probe geometry may lead to image distortion or damage to the ultrasound probe.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed that during the device evaluation, the subject device exhibited indentation and elongation at the tip of the insertion.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: 19639349
• Report Number: 3002808148-2024-34403
• Device Sequence Number: 8793578
• Product Code: ITX
• UDI-Device Identifier: 04953170368561
• UDI-Public: 04953170368561
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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: 05/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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