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

Model Number	TB-0535FC
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure, this subject device did not trigger an alarm during use.Although the generator involved, it was confirmed that the issue was caused by the knife head and not related to the generator.The procedure was then completed with a competitor device which resulted in a procedural delay of more than 30 minutes while the patient was under sedation.There were no reports of adverse patient sequelae.
Additional Manufacturer Narrative
The device was returned to olympus for inspection.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.The likely cause of error codes u504 and u601 is due to the loose connection of the subject device and the generator.Error message u512 may occur if the tb is not immersed in water to the extent specified in the instruction manual.The event was conservatively classified as a serious injury due to the procedure allegedly being prolonged by 30 or more minutes.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED 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: 21030621
• Report Number: 9614641-2024-20144
• Device Sequence Number: 4119942
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: 04953170337574
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111202
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2024

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: TB-0535FC
• Device Lot Number: 42K(NMGBA)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GENERATORS: USG-400; HF UNIT "ESG-400"
• Patient Sex: Unknown