MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW TYPE X; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0009OFX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/address line 1: (b)(6) - added due to character limitation in respective field.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 the subject device handpiece disassembled while in use due to loosening.The issue occurred during a therapeutic thyroidectomy procedure.The procedure was completed with an olympus back-up device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: it is presumed the cover that was covering the insertion portion detached.The device was then presumed to be used in the procedure, causing internal components that connect the insertion portion and the handle to become detached.As a result of the detachment of the internal components, the insertion portion became detached from the handle.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be detected/prevented by following the instructions for use which state: "drawing number and revision number of ifu: rc3904 07 ¿ be sure to perform the preparation and inspection described in this chapter before use.Also, inspect the ancillary equipment to be combined with the thunderbeat instrument according to the instruction manuals for the equipment.Should any irregularity be observed with the thunderbeat instrument, do not use it.Inspect it as described in chapter 8, ¿troubleshooting¿ in the instruction manual for the ultrasonic generator.If the irregularity is still not resolved after troubleshooting, contact olympus.Using the thunderbeat instrument while any irregularity is observed may cause malfunction and may injure the surgeon, surgical staff, and/or patient.¿ should any irregularity (error window, abnormal noise, abnormal output, abnormal operation, abnormal appearance, etc.) or malfunction be observed while using the thunderbeat, stop the use and withdraw the instruments from the body cavity.Do not withdraw the transducer plug from the ultrasonic generator.Check the equipment by referring to chapter 8, ¿troubleshooting¿, in the instruction manual for the ultrasonic generator.If the irregularity remains after troubleshooting, replace the transducer.If this does not resolve the issue, replace the thunderbeat instrument.If the irregularity remains unresolved, contact olympus.".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 customer.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 23877784
• Report Number: 9614641-2025-02135
• Device Sequence Number: 17310727
• Product Code: GEI
• UDI-Device Identifier: 04953170394584
• UDI-Public: 04953170394584
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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-0009OFX
• Device Lot Number: 51K24
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown