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 Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ultrasonic surgical device's tip broke and fell into the patient¿s body during a therapeutic thyroid procedure.The broken part was retrieved using forceps.There was a procedural delay of less than 30 minutes, back-up device used to complete the procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d9, h3, h7, h9.The device was returned to olympus for inspection.The product analysis confirmed the reported event of "tip broken." the probe was broken.The fragment of the probe was not returned.A scratch was observed around the broken surface of the probe.The surface of the broken portion was inspected; a crack was spreading out from scratch.There were no traces of contact with the probe on the non-insulated parts.The reported event is inferred to have occurred through the following mechanism.1) during output in seal & cut mode, the probe came in contact to metal, a surgical instrument or a hard tissue.2) due to ultrasonic vibration, scratches were generated on the probe.3) a force to activate the output in seal & cut mode, or a force to grasp the tissue was applied to the probe.Therefore, cracks were generated at the scratched area.4) a force was applied to the probe causing it to break off.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 was received from the customer.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the final investigation.Updates: h2, h11.The reported events and identified malfunction are inferred to have occurred through the following mechanism.1.During output in seal and cut mode, the probe came in contact to metal, a surgical instrument or a hard tissue.2.During output in seal & cut mode in state no.1, the coating of the probe peeled off.Also, a scratch was generated.3.During output in seal mode in state no.1, probe damage error occurred.4.A force was applied to the probe causing it to break off.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: 23660275
• Report Number: 9614641-2025-01973
• Device Sequence Number: 18673033
• Product Code: GEI
• UDI-Device Identifier: 04953170383588
• UDI-Public: 04953170383588
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0520FCS
• Device Lot Number: 51K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 01/19/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003995201-12/09/2024-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown