MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 20 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0520IC
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
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 by the customer that during a therapeutic procedure, while the patient was under sedation, the teflon pad peeled off the tool shaft of the thunderbeat device.The patient was under sedation, and due to this issue, the procedure was delayed by 30 minutes.The intended procedure was completed successfully with an olympus backup device.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d4, h3.The device was returned to olympus for inspection and the reported failure of teflon came off the tool shaft was confirmed.Based on the results of the investigation, the most probable cause of the complaint is cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 the customer.

• Brand Name: THUNDERBEAT 5 MM, 20 CM, INLINE GRIP
• 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: 21865011
• Report Number: 9614641-2025-00538
• Device Sequence Number: 4696017
• Product Code: GEI
• UDI-Device Identifier: 04953170308710
• UDI-Public: 04953170308710
• Combination Product (Y/N): N
• PMA/510(K) Number: K132703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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-0520IC
• Device Lot Number: 39K13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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