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 Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the evaluation that the thunderbeat 5 mm, 35 cm, front-actuated grip type s exhibited that the tissue pad was worn out and partially peeled off.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.In addition, the investigation found that the tissue pad was worn out and partially peeled off.The identified malfunction 2 is inferred to have occurred through the following mechanism.1.During output activation in seal & cut mode, nothing was grasped between the grasping section and the distal end of the probe (including after tissue resection).As a result, the tissue pad was worn out.2.Due to friction between the grasping section and the distal end of the probe, abnormal heat was generated, which may have caused the tissue pad to partially peel off.Based on the results of the investigation, the definitive root cause of the issue could not be determined.Olympus will continue to monitor the field performance of this device.

• 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: 25250573
• Report Number: 9614641-2026-00533
• Device Sequence Number: 21469584
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 05/21/2026

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: Other
• Device Model Number: TB-0535FCS
• Device Lot Number: 52K26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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