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

Model Number	TB-0009OF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for evaluation by the distributor for wear of tissue pad during use in a therapeutic mammary gland surgery.After approximately two to three outputs of the device frequent error messages were observed for the device.The transducer was replaced; however, the error messages continued.The device was then replaced with a new device of the same model number and procedure completed without any delay.The tissue pad was noted to have wear.The patient did not need additional anesthesia.There is no harm or adverse impact to the patient.The intelligent tissue monitoring (itm) setting was on during the procedure.The settings are seal and cut 1, seal 3.The device was inspected prior to sue with no anomaly noted.The connections to the generator were checked.The transducer cords and other medical device cords were not bundled together.Upon evaluation of the returned device, it was observed that there was severe wear of the tissue pad at the tip where there was contact with the tip of the probe.This medwatch is being submitted for the reportable issue of severe wear of the tissue pad as observed during device evaluation.The doctor using the device in the procedure is very experience.This is the first time such an event occurred with the doctor.The doctor had no idea what caused the event.
Additional Manufacturer Narrative
The device is returned, and an evaluation completed for it.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Upon inspection and testing, it was observed that severe wear of the tissue pad at the tip where there was contact with the tip of the probe.There was a contact mark on the probe which indicates that the probe was contacting the non-insulated area.Upon inspection of the probe, an error was not detected.When the output was activated in seal mode by closing the grasping section, short circuit error was detected.The tissue pad will wear out when the device is activated in seal and cut mode.Therefore, the test is performed in seal mode.Based on the result of investigation, a likely mechanism causing the reported event might be the following: 1.The grasping section was closed without grasping anything while the output activation in seal and cut mode was activated, (this includes after tissue resection) causing the tissue pad to severely worn out.2.Due to severely worn out of the tissue pad, the non-insulated area of the grasping section came into contact with the probe.3.The output was activated while the non-insulated area of the grasping section was contacting the probe causing a seal and cut short circuit error u508.It also generated a contact mark.The instructions for use includes the following statements that warn against the issue: ·do not activate output in seal and cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ when cutting and vessel sealing is performed in seal and cut mode, apply light tension on the tissue so that users can confirm it is transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation.

• 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: 16426839
• Report Number: 9614641-2023-00258
• Device Sequence Number: 2644980
• Product Code: GEI
• UDI-Device Identifier: 04953170343346
• UDI-Public: 04953170343346
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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
• Device Lot Number: 2YK 18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: USG-400.ESG-400.TD-TB400.
• Patient Sex: Female