MAUDE Adverse Event Report: GYRUS ACMI, INC. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
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	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic colectomy, one of the blades of the ultrasonic surgical device broke and stuck in the patient¿s abdominal cavity.The piece was retrieved and the procedure was completed with a backup device.
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 the results of the final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported failure was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, the most probable cause of the customer¿s reported event was the probe was broken at 16.02mm from it¿s distal end due to stress problem, force causing probe to break.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, 45 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 ; 5082077661
• MDR Report Key: 24087582
• Report Number: 3011050570-2026-00066
• Device Sequence Number: 15881203
• Product Code: GEI
• UDI-Device Identifier: 04953170409684
• UDI-Public: 04953170409684
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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-0545FCS
• Device Lot Number: KR489981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• 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