MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0520FCS
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the evaluation, the thunderbeat 5 mm, 20 cm, front-actuated grip type s exhibited peeling of the probe coating.There was no report of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.In addition, the investigation found peeling of the probe coating.Based on the investigation results, it is likely the reported phenomenon occurred by the following mechanism: 1.During output activation in seal & cut mode, the probe came into contact with metal, a surgical instrument, or hard tissue.2.Due to ultrasonic vibration, the coating of the probe peeled off, and scratches were generated and causing error.Based on investigation results, the root cause of the reported issue could not be identified/determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 20 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: 23576595
• Report Number: 9614641-2025-01900
• Device Sequence Number: 9641107
• Product Code: GEI
• UDI-Device Identifier: 04953170383588
• UDI-Public: 04953170383588
• Combination Product (Y/N): N
• 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): 11/17/2025

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: TB-0520FCS
• Device Lot Number: 49K24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown