MAUDE Adverse Event Report: GYRUS ACMI, INC. THUNDERBEAT II SHEARS WITH ULTRASONIC MODE, 5 MM, 35 CM; ULTRASONIC SURGICAL DEVICE

Model Number	TB2-0535FC
Medical Device Problem Codes	Melted (1385); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for inspection; however, a photo was provided for visual inspection.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.It is likely prolonged use led to the malfunction.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 reported the ultrasonic surgical shears' resin cover and tissue pad were found to be completely melted and no longer present.The issue occurred during a therapeutic laparoscopic pelvic exenteration, which was completed with an olympus back-up device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide h7 and h9 data.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: THUNDERBEAT II SHEARS WITH ULTRASONIC MODE, 5 MM, 35 CM
• 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: 24987600
• Report Number: 3011050570-2026-00465
• Device Sequence Number: 10451004
• Product Code: GEI
• UDI-Device Identifier: 04953170440014
• UDI-Public: 04953170440014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K252150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: Health Professional
• Device Model Number: TB2-0535FC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 3011050570-03/05/2026-00
• Patient Sequence Number: 1
• Patient Sex: Unknown