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	Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the front-actuated grip to the service center for a separate issue.During the device analysis, the evaluation indicated that probe was broken at 16.16 mm from its distal end and the tissue pad in the grasping section was worn away.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.A root cause could not be identified.Based on the results of the investigation, it is likely a stress problem and wear problem led to the malfunctions.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.

• 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: 25337326
• Report Number: 3011050570-2026-00592
• Device Sequence Number: 5294903
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Remedial Action: Recall
• 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
• Device Lot Number: PW310361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• 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: 3003995201-12/08/2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown