MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT TRANSDUCER

Model Number	TD-SB400
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the sonicbeat transducer exhibited the tissue pad was severely worn.There were traces of contact with the probe on the non-insulated parts.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation, it is likely the following led to the malfunction: the event can be detected/prevented by following the instructions for use which state: 1.Ultrasonic waves were output while the tissue was grasped at the tip of the grasping section, which caused contact between the probe and the tissue pad at the rear end of the grasping section, resulting in severe abrasion of the tissue pad.2.Wear of the tissue pad caused the gripper to come into contact with the probe.3.Contact marks were left as ultrasound was output while the gripper and probe were in contact.4.The probe was subjected to the load of ultrasound output and tissue grasping, which caused cracks starting from the contact marks, which resulted in an error.Drawing number and revision number of ifu: ge8031 13.If any irregularity is observed, take proper remedial actions by referring to chapter 8, ¿troubleshooting¿ in the instruction manual for the ultrasonic generator.Do not use the transducer on the patient if any irregularity is observed with the equipment.Otherwise, the system may not work properly and serious injury to the surgeon, surgical staff and/or the patient may result.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SONICBEAT TRANSDUCER
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21990881
• Report Number: 9614641-2025-00689
• Device Sequence Number: 17265093
• Product Code: LFL
• UDI-Device Identifier: 04953170306808
• UDI-Public: 04953170306808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211838
• 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): 05/08/2025

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: Other
• Device Model Number: TD-SB400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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