MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during set up for the procedure, the probe tip on the thunderbeat device was broken off.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is submitted to document the findings and conclusions of the legal manufacturer's final investigation into the reported event.Additional information: d4, d9.The affected device was not returned to olympus america inc.For physical inspection.As a result, the reported malfunction, specifically, a broken probe tip, could not be confirmed through direct device evaluation.Based on the findings of the completed investigation, and in the absence of the returned device for physical examination, a definitive root cause for the reported event could not be established.No conclusive determination regarding the failure mode or contributing factors could be made.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
No additional information received from the customer.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• 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: 24402605
• Report Number: 9614641-2026-00216
• Device Sequence Number: 12817870
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: TB-0535FCS
• Device Lot Number: 55K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown