MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535FCS
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic total laparoscopic hysterectomy (tlh), the teflon tissue pad on the thunderbeat device peeled off after six (6) activations at the start of the procedure, resulting in an extended procedural delay of less than 30 minutes while the patient was under sedation.The procedure was subsequently completed using an olympus backup device, and no patient harm was reported in association with this event.
Additional Manufacturer Narrative
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 total laparoscopic hysterectomy (tlh), the teflon tissue pad on the thunderbeat device peeled off after six (6) activations at the start of the procedure, resulting in an extended procedural delay of less than 30 minutes while the patient was under sedation.The procedure was subsequently completed using an olympus backup device, and no patient harm was reported in association with this event.
Additional Manufacturer Narrative
Fields updated: d4, h2, h4, h6, h11.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 the field performance of this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23844258
• Report Number: 9614641-2025-02108
• Device Sequence Number: 9835891
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2026

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: TB-0535FCS
• Device Lot Number: 5JB07053K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• 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