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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation, the definitive root cause of the issue could not be determined.The event can be prevented by following the instructions for use which state: should any irregularity (error window, abnormal noise, abnormal output, abnormal operation, abnormal appearance, etc.) or malfunction be observed while using the thunderbeat, stop the use and withdraw the instruments from the body cavity.Do not withdraw the transducer plug from the ultrasonic generator.Check the equipment by referring to chapter 8, ¿troubleshooting¿, in the instruction manual for the ultrasonic generator.If the irregularity remains after troubleshooting, replace the transducer.If this does not resolve the issue, replace the thunderbeat instrument.If the irregularity remains unresolved, contact olympus.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 observed that during the device evaluation, the ultrasonic surgical device ptfe pad (teflon pad) was inspected and found the pad is separated from the jaw exposing metal.There was no 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: 25339192
• Report Number: 3011050570-2026-00598
• Device Sequence Number: 5294987
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: 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: 03/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/29/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown