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); Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: the customer returned two devices for evaluation, neither of which matched the item and lot # initially reported (as captured in initial mdr of related report number).Customer could not discern which product was involved with the reported event.Therefore, the results of both device investigation will be provided upon completion.D4, h4: 1.Tb-0520fcs - lot no: 54k 08, expiry date: 31-mar-2028, mfg date: 08-apr-2025.2.Tb-0520fcs - lot no: 57k 31.The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the thunderbeat's probe broke immediately after it was activated during unspecified use.Additional details were requested from the customer but the information was unknown.There was no reported patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the device lot number and submit the results of the final investigation.Refer to 9614641-2026-00006 for tb-0520fcs device with lot number 54k 08.The device was returned to olympus for inspection and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the tissue pad was peeling off.The probe was broken at 13.70 mm from its distal end with the broken probe tip returned; however, the device was received with an externally intact tip.During reprocessing, the probe tip broke off.Analysis revealed that there was a pre-existing crack in the probe, which was not externally visible.A root cause could not be identified.Based on the results of the investigation, it is likely the following mechanism led to the malfunction: 1.The output was activated in seal & cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.The output in seal & cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark developed.4.A force to activate the output in seal &cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark.5.A force was applied to the probe causing it to break.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
It was reported the thunderbeat's probe broke immediately after it was activated during unspecified use.Additional details were requested from the customer but the information was unknown.There was no reported patient injury or medical intervention associated with this event.

• 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: 24269295
• Report Number: 9614641-2026-00153
• Device Sequence Number: 10726688
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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-0520FCS
• Device Lot Number: 57K 31
• Date Returned to Manufacturer: 01/02/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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): 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
• Patient Sex: Unknown