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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparotomy procedure, the ultrasonic surgical device clamp (insulation coating) broke.An audible alert sounded and a message appeared on the generator asking for the clamp to be changed.The physician noticed this immediately and was able to retrieve the piece of metal from the patient's abdomen.There were no further reports of patient harm.
Additional Manufacturer Narrative
E1 - (b)(6).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 correction and the results of the legal manufacturer's final investigation.Updated fields:d4 - expiration date, d9, h3, h4, h6, h7 and h9.Corrected field: d4 - lot #.The device was returned to olympus for inspection and the reported failure was confirmed.The probe was broken at 15.72 mm from its distal end, broken probe tip was returned.A definitive root cause could not be identified.The most probable cause of the complaint is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.The exact cause of the event couldn't be exclusively identified.Based on the result of analysis and the result of investigation in the past, a likely mechanism causing the reported event might be the following: broken - probe and h-electrode contact: the output was activated in seal and 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.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.The output in seal and 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.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.A force was applied to the probe causing it to break.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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.

• 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: 24054782
• Report Number: 9614641-2026-00051
• Device Sequence Number: 13267708
• Product Code: GEI
• UDI-Device Identifier: 04953170383588
• UDI-Public: 04953170383588
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 58K 22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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