MAUDE Adverse Event Report: Gyrus ACMI, Inc. THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535FCS
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	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the thunderbeat surgical instrument to the service center for a separate issue.During olympus¿ device analysis it was indicated that the thunderbeat surgical instrument's tissue grasping insulation pad was split and detached.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection when the reportable malfunction was observed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the issue was attributed to stress related problems, however, a definitive root cause could not be established.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.If sparks are discharged frequently from the grasping section during output, the grasping surface (white tissue pad surface) may be worn out.Continued use under this condition may result in a scratch on the probe tip.This could lead to the probe tip breaking and falling off into the body cavity during output.The thunderbeat instrument should be used for soft tissue.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, or other instruments (e.G.,uterine manipulator, forceps, and others).Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/splitting/protruding/partial separating of the tissue pad.In turn, the probe may break before displaying an error window or generating an alarm tone.Do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, positioning the tissue, twisting the shaft, or rotating the rotation knob.Manipulate and isolate the targeted tissue with another instrument, grasp the targeted tissue with the thunderbeat instrument, and then activate.Otherwise, it may cause the deforming/splitting/protruding of tissue pad or a scratch on the probe tip by interference with the other parts, which could result in the probe tip breaking and falling off inside the body cavity.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle.Also, do not activate the output, while torque is applied to tissue over the handle, in this instance release the torque, re-grasp the tissue, and re-activate output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.When cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm it is 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.Be careful not to break the probe tip or separate the tissue pad by the load imposed on the probe tip and the tissue pad when the instruments are withdrawn from the body cavity and/or the instruments are cleaned.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, 35 cm, Front-actuated Grip Type S
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50805862
• Report Number: 3011050570-2026-00908
• Device Sequence Number: 16099510
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: PW310362
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: 3003995201-12/08/2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown