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

Model Number	TB-0009OFX
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and the customer's allegation was confirmed.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: cause linked to device but unable to trace more specifically.During the output activation in seal & cut mode, nothing was grasped in between the grasping section and the distal end of the probe (this includes after tissue resection).Therefore, the tissue pad was worn out.Due to friction between the grasping section and the distal end of the probe, abnormal heat was generated.This might have caused the tissue pad to partially peel off.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.
Event or Problem Description
It was reported the thunderbeat malfunctioned, the tip of the pad came loose and floated away during output.There was no loss inside the patient.The issue occurred during sedation, before a therapeutic unilateral neck dissection, and was completed using an olympus back-up device.There were no reports of patient harm.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 20766585
• Report Number: 9614641-2024-20019
• Device Sequence Number: 12860305
• Product Code: GEI
• UDI-Device Identifier: 04953170435829
• UDI-Public: 04953170435829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2024

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-0009OFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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