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 Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.In addition, the investigation found that the teflon pad was worn at the mid-section, and signs of thermal damage were noted on the probe.Based on the results of the investigation, the most probable cause of this complaint is traced to component failure, which is expected or random component failure without any design or manufacturing issue.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed during the evaluation that the thunderbeat 5 mm, 35 cm, front-actuated grip type s exhibited that the teflon pad was worn at the mid section, and signs of thermal damage were noted on the probe.There were no reports of patient involvement.

• 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 ; 5082077661
• MDR Report Key: 25339348
• Report Number: 3011050570-2026-00599
• Device Sequence Number: 5280633
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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
• Patient Sex: Unknown