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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1- initial reporter establishment name: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during a therapeutic laparoscopic pancreatic surgery that was performed in the operating room, the patient developed lymphocele.The procedure itself was completed without issue; however, after the procedure, chylous ascites and lymphocele into the left pelvic cavity were observed and showed no signs of decreasing, and lymph leakage was observed in the left pelvic cavity and lymphangiography was then performed.Subsequently, the leakage of lymph fluid decreased, and the patient is scheduled for release on (b)(6) 2025.Additionally, the physician has commented that other factors may be considered (such as insufficient clips, etc.).This is not a life-threatening procedure that required immediate intervention and the patient's condition was stable.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction on h6- health effect - clinical code: from e2403 to e2015.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
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the 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: 23949760
• Report Number: 3011050570-2026-00006
• Device Sequence Number: 15422524
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TB2-0535FC
• Device Lot Number: KR497172
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/24/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/02/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown