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)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an exploratory laparotomy for an intestinal obstruction/perforation procedure, the tip of the thunderbeat device broke off completely from the shaft.The event occurred during the dissection of the mesocolon of the tract to be respected.There was a procedural delay of less than 30 minutes related to the time needed to find and connect a new identical device in order to continue the dissection.The intended surgery was completed as planned with a colon resection and anastomosis.The patient did not suffer any damage related to the malfunction of the device and had a postoperative course consistent with the surgery performed.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
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 additional information and the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.The probe was broken at 16.01 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.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
Additional information was received from the customer that the ultrasonic surgical device detached and fell into the patient's intestinal loops.The tip was retrieved by the surgeon using vascular forceps.There were no further reports of patient harm.

• 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: 23450605
• Report Number: 9614641-2025-01810
• Device Sequence Number: 15713422
• Product Code: GEI
• UDI-Device Identifier: 04953170383571
• UDI-Public: 04953170383571
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 51K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown