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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the thunderbeat's grasping jaw insulation pad became detached during a therapeutic thyroidectomy procedure.The procedure was completed with a backup olympus device.There were no reported fragments within the patient's anatomy.There was no patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
No additional customer info.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s final investigation.Additional data: d4 expiration date, d8, d9, h3, h4 the device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, the issue was attribute to wearing of the insulation pad, however, a definitive root cause could not be established.It is likely the following led to the malfunction: 1.The grasping section was closed without grasping any tissue (including after tissue resection) while the output was activated in seal & cut mode, leading to partial peeling of the tissue pad.2.Force applied to the peeled tissue pad caused it to detach.The event can be detected/prevented by following the applicable chapters in the instructions for use which state: ¿ do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ when cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation.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 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: 22929143
• Report Number: 9614641-2025-01464
• Device Sequence Number: 9162903
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: Health Professional
• Device Model Number: TB-0009OFX
• Device Lot Number: 4XK17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown