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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the thunderbeat surgical instrument's tip broke off in half and fell into the abdominal cavity during a laparoscopic hysterectomy.Initially, the thunderbeat reported a malfunction.The tip did not hit metal and was not crusted, but was in normal use.Nothing was visible externally.The thunderbeat machine was turned off and restarted.The procedure continued normally for a short time until the message came back that the tip was damaged.When the handpiece was out of the abdominal cavity, it was noticed that one half of the tip had broken off and fallen into the abdominal cavity.The piece of the tip was easily found and removed.This resulted in a delay in the procedure of 30 minutes.The procedure was completed using a back up device.There were no reports of patient harm.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 25340519
• Report Number: 9614641-2026-00562
• Device Sequence Number: 10003001
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: KR451992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown