MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0009OF
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the polymer lining on the single use thunderbeat device had come off.Still attached to part of the device.There was no report of patient harm associated 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
No additional information received from the 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.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.Three attempts were performed to obtained additional information, but no response was received from the customer.

• Brand Name: THUNDERBEAT OPEN FINE JAW
• 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: 21734077
• Report Number: 9614641-2025-00402
• Device Sequence Number: 11757586
• Product Code: GEI
• UDI-Device Identifier: 04953170343346
• UDI-Public: 04953170343346
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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-0009OF
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown